Single port instrument access device

ABSTRACT

Disclosed are medical devices for surgical procedures, especially procedures that involve the manipulation of surgical instrument end effectors close to the skin surface at an incision site. In accordance with some embodiments, an instrument access device is configured to couple to a wound retractor at a distal end of the device and to receive a multiple instrument entry guide in a port at the proximal end of the instrument access device, with an envelope between the distal and proximal ends defining a sealed cavity for maintaining insufflation pressure. Various embodiments provide means for rotating an assistant port in the envelope about a port that receives the instrument entry guide without twisting the envelope. Also disclosed are various envelope shapes. Also disclosed is an instrument entry guide that aligns surgical instrument shafts.

CLAIM OF PRIORITY

This application claims the benefit of priority to U.S. ProvisionalPatent Application No. 62/908,501, filed on Sep. 30, 2019, which isincorporated by reference herein in its entirety.

TECHNICAL FIELD

This document relates generally to medical devices, and moreparticularly, to medical devices for use in minimally invasive surgicalprocedures.

BACKGROUND

Surgical systems that operate at least in part with computer-assistedcontrol (“telesurgical systems”), such as those employed for minimallyinvasive medical procedures, can include large and complex equipment toprecisely control relatively small instruments. Such systems aresometimes referred to as robotic surgical systems or surgical robots.The da Vinci® Surgical Systems commercialized by Intuitive Surgical,Inc. are examples of telesurgical systems.

Various telesurgical system architectures exist. Some systemarchitectures enable multiple (e.g., two, three, four, or more) surgicalinstruments to enter the body through a single body opening (surgicalincision or natural orifice), and these systems are sometimes referredto as “single-port” systems (e.g., the da Vinci SP® Surgical System).Other system architectures enable multiple surgical instruments to enterthe body individually at corresponding multiple locations, and thesesystems are sometimes referred to as “multi-port” systems (e.g., the daVinci Xi® Surgical System). Persons of skill in the art will understandthat multi-port systems may sometimes be configured during surgery tooperate through a single natural body orifice, such as the mouth oranus, or through a single incision (e.g., Intuitive Surgical's SingleSite® technology used with a da Vinci Xi® Surgical System). Persons ofskill in the art will also understand that single- and multi-portconfigurations may be combined simultaneously in a single telesurgicalsystem (e.g., two or more instruments inserted via one body opening, andone or more other instruments inserted via one or more correspondingother body openings).

Surgical instruments used during minimally invasive surgery typicallyinclude an endoscopic camera or therapeutic end effector mounted at theend of a long, slender instrument shaft. Since instrument end effectorsare typically located deep within the body during surgery, telesurgicalsystems are designed to constrain rotation of the instrument at a pointlocated on the instrument's shaft, often referred to as a remote centerof motion. Either kinematic hardware structure or control systemsoftware design (or a combination of the two) may be used to impose thisremote center of motion constraint. To minimize tissue trauma duringsurgery, the constrained remote center of motion is typically located ator near the body opening through which the instrument enters.

If a telesurgical system is to be used at or near the body opening,however, then several challenges exist. First, to provide sufficientdistance between an instrument's constrained remote center of motion andits end effector, the constrained remote center of motion may need to belocated proximally of the body opening, sometimes by several centimetersor more. Second, if part of the surgery is performed proximally of theultimate surgical site (e.g., using the telesurgical system to performdissection to reach the ultimate surgical site), there needs to be aneasy way to relocate the constrained remote center of motion distally asthe surgery progresses towards the deepest surgical site in thepatient's body. A third challenge exists if insufflation is to be usedin the body cavity in which the ultimate surgical site is located (e.g.,the abdomen, the rectum). When the constrained remote center of motionis located at the patient's body wall, and when cannulas are used tointroduce instruments past the body wall, seals in the cannulas are usedto maintain insufflation gas pressure within the body cavity both whenan instrument is inserted through the body wall via the cannula and whenthe instrument is removed from the cannula. But if the cannula islocated proximal of the body opening, insufflation gas pressure muststill be maintained.

Further, for a single-port system in which two or more instruments canbe introduced into a patient and moved as a single instrument cluster,these challenges become more complex because the constrained remotecenters of motion for the two or more instruments are located at thesame point or close to one another. In addition, single-port systeminstruments may be designed with joints that allow them to be insertedclose to one another, but then individually spread apart after passingbeyond the body wall to provide triangulation to more effectivelyperform surgery. And, a further challenge exists during the use of asingle-port system if an additional instrument (either a telesurgicalsystem instrument or a manually operated instrument) is to be introducedto assist the surgery, because the cluster of single-port systeminstruments blocks some access locations of the additional instrument.

What is required, therefore, is a way to allow a single-porttelesurgical system to be used with its constrained remote center ofmotion located proximally of the patient's body opening to performsurgery at or near the patient's body opening, to allow insufflation gaspressure to be maintained during this surgery, and also to allow anassist instrument to be introduced to any desired location in relationto the cluster of telesurgical system instruments during this surgery.

SUMMARY

Examples according to this disclosure include a medical device thatallows a multiple instrument entry guide to be located outside apatient's body and that simultaneously provides a sealed space betweenthe entry guide and an opening in the patient's body wall to maintaininsufflation. In this description, such a medical device is referred toas an “instrument access device”. The instrument access device includesan envelope, and the envelope includes a distal opening at a distal end,a proximal opening at a proximal end, and an interior cavity between thedistal and proximal openings. The envelope may have various shapes, suchas a spheroid shape, ellipsoid shape, ovoid shape, barrel shape,lenticular shape, or bellows shape, for example.

At the distal end, the envelope can be coupled to a medical port device,such as a wound retractor, via a distal coupling component (e.g., aclamp) at the distal opening. At the proximal end, the envelope can becoupled, via a proximal coupling component, to a telesurgical system.The proximal coupling component is configured to accommodate multiplesurgical instruments through a single opening and seal againstinsufflation gas escaping through the single opening.

The instrument access device is optionally configured to receive aninsufflation gas and to maintain insufflation pressure within a cavityin the body of a patient and within the interior cavity of the envelope.The pressurized and sealed envelope cavity provides an operating spacefor shafts of multiple instruments of a telesurgical system toarticulate outside the patient's body such that instrument end effectorsare located at or near the surface of the body at the port devicecoupled to the instrument access device.

The proximal coupling component of the instrument access device islocated at and is coupled to the proximal opening of the envelope. Insome examples, the proximal coupling component includes a first port anda second port. The first port may be, for example, configured to receivean entry guide receptacle and, in the entry guide receptacle, aninstrument entry guide (also simply “entry guide”), while the secondport may be, for example, an assistant port. The assistant port may, forinstance, support the introduction of a manually-operated instrument,items required for surgery, and removal of large and/or delicatespecimens during a procedure. The proximal coupling component includes acenter, and the first and second ports are located eccentrically on theproximal coupling component.

In an example, an entry guide receptacle is received in the first portof the instrument seal assembly. The entry guide receptacle workssimilarly to a cannula that would be received in the wound in caseswhere the end effectors are located deep inside the body. In someexamples, the entry guide receptacle includes an instrument entry guideseal, which is configured to receive and seal an instrument entry guide.Compared with instrument entry guides received in a cannula in thewound, the instrument entry guide received, remote from the wound, inthe entry guide receptacle within the first port may be shortened.

Instrument access devices in accordance with this disclosure optionallyalso include a mechanism configured to rotate the second (e.g.,assistant) port around the first port without the envelope twistingabout a central axis of the envelope. In some examples, the mechanismincludes a gear train. In another example, the mechanism includes alinkage. Additionally, in examples, the mechanism can include a clutch(may also be referred to as torque limiting clutch or torque limiter),which disengages at least part of the mechanism in response to athreshold applied torque.

This Summary is intended to provide an overview of subject matter of thepresent patent application. It is not intended to provide an exclusiveor exhaustive explanation of the invention. The detailed description andaccompanying drawings provide further information about various aspectsof the inventive subject matter of the present patent application.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily to scale, like numeralsdescribe similar components in different views. Like numerals havingdifferent letter suffixes represent different instances of similarcomponents. The drawings illustrate generally, by way of example, butnot by way of limitation, various embodiments discussed in thisdocument.

FIG. 1A is a schematic cross-sectional view of an instrument accessdevice used together with a telesurgical system, in accordance withvarious embodiments.

FIGS. 1B-1D are schematic cross-sectional views that illustrate in moredetail coupling of the distal end of the instrument access device ofFIG. 1A to a port device, in accordance with various embodiments.

FIG. 1E is a schematic cross-sectional view that illustrates in moredetail proximal elements of the instrument access device of FIG. 1 , inaccordance with various embodiments.

FIG. 2 is a schematic top view that illustrates operating features ofproximal coupling component 10.

FIG. 3 is a perspective view of an example telesurgical system inaccordance with various embodiments.

FIG. 4A is an exploded perspective view of an example instrument accessdevice in accordance with various embodiments.

FIG. 4B is an exploded perspective view depicting additional details ofthe instrument access device of FIG. 4A.

FIG. 4C is a bottom plan view depicting a gear train, in accordance withone embodiment, for rotating one port within an instrument access deviceas depicted in FIG. 4A around another port without twisting an envelopeof the device.

FIGS. 4D and 4E are bottom plan views depicting the gear train of FIG.4C in different rotational positions.

FIG. 5A is a bottom perspective view depicting a gear train, inaccordance with another embodiment, for rotating one port within aninstrument access device as depicted in FIG. 4A around another portwithout twisting an envelope of the device.

FIG. 5B-5D are bottom plan views depicting the gear train of FIG. 5A indifferent rotational positions.

FIG. 6A is a bottom perspective view depicting a gear train, inaccordance with yet another embodiment, for rotating one port within aninstrument access device as depicted in FIG. 4A around another portwithout twisting an envelope of the device.

FIG. 6B-6D are bottom plan views depicting the gear train of FIG. 6A indifferent rotational positions.

FIG. 7A is a top perspective view of another example instrument accessdevice in accordance with various embodiments.

FIG. 7B is a top plan view depicting a linkage, in accordance with oneembodiment, for rotating one port within an instrument access device asdepicted in FIG. 7A around another port without twisting an envelope ofthe device.

FIGS. 7C and 7D are top plan views depicting the linkage of FIG. 7B indifferent rotational positions.

FIG. 8A is a perspective view of an example instrument access deviceincluding an ovoid envelope in accordance with one embodiment.

FIG. 8B is a perspective view of an example instrument access deviceincluding a spherical envelope in accordance with one embodiment.

FIG. 8C is a perspective view of an example instrument access deviceincluding an oblate spherical envelope in accordance with oneembodiment.

FIG. 8D is a perspective view of an example instrument access deviceincluding a bellows-shaped envelope in accordance with one embodiment.

FIG. 8E is a perspective view of an example instrument access deviceincluding a lenticular envelope in accordance with one embodiment.

FIG. 8F is a perspective view of an example instrument access deviceincluding a barrel-shaped envelope in accordance with one embodiment.

FIG. 9A is a perspective view of an entry guide in accordance withvarious embodiments.

FIG. 9B is a top view of the proximal end of the entry guide of FIG. 9A.

FIG. 9C is an exploded perspective view depicting additional details ofthe entry guide of FIG. 9A.

FIG. 9D is a cross-section taken along a longitudinal axis of the entryguide of FIG. 9A.

FIGS. 10A-10C depict an example medical device including a clutch inaccordance with examples of this disclosure.

FIGS. 11A and 11B depict an alternative clutch that can be employed ininstrument access device in accordance with examples of this disclosure.

DETAILED DESCRIPTION

FIGS. 1A-IE are schematic cross-sectional views that illustrate aspectsof various embodiments of an instrument access device 1 that is usedtogether with a telesurgical system 2. As shown in FIG. 1A, instrumentaccess device 1 includes an envelope 3, which has a proximal opening 4and a distal opening 5. The interior 6 of envelope 3 is empty so thatone or more surgical instruments can be inserted through proximalopening 4 into the interior 6, and the instruments can pass through andexit interior 6 through distal opening 5. Envelope 3 may have variousshapes as described in more detail below.

For reference, a center longitudinal axis 7 of instrument access device1 and envelope 3 is defined extending through the proximal and distalopenings 4,5. As illustrated, in this specification, locationsassociated with the instrument access device are denoted as “proximal”or “distal”. The term “distal” means a location closer to a surgicalsite. The term “proximal” means a location farther away from thesurgical site and, thus, closer to the mechanical ground of thetelesurgical system 2. Similarly, as indicated by the arrows as shown,the—distal direction generally denotes the direction along theinstrument access device away from the mechanical ground of telesurgicalsystem 2 and towards a surgical site, and the proximal directiongenerally denotes the direction along the instrument access device awayfrom the surgical site and towards the mechanical ground of telesurgicalsystem 2. And for still further reference, a world reference frame 8 isarbitrarily defined and is fixed in space. Typically, the instrumentaccess device 1, when in use, is oriented with its proximal opening 4located above the distal opening 5 relative to the patient's body (i.e.,the proximal opening being the “top opening”, and the distal opening 5being the “bottom opening”), as shown, such that surgery is performedfrom above. Note, however, that the instrument access device 1 can beused in any orientation.

Instrument access device 1 includes a distal coupling component 9 and aproximal coupling component 10. Distal coupling component 9 is coupled,optionally removably or fixedly, to envelope 3 at distal opening 5, andproximal coupling component 10 is coupled, optionally removably orfixedly, to envelope 3 at proximal opening 4.

As shown, proximal coupling component 10 is removably coupled tomechanical ground at a coupling 11. Any suitable coupling type may beused, and proximal coupling component 10 may be coupled, optionally, tomechanical ground via telesurgical system 2 (e.g., where telesurgicalsystem 2 includes a proximal portion of coupling 11), via another pieceof operating room equipment (e.g., an operating table), or via any othersuitable supporting structure that allows proximal coupling component 10to be placed at a desired position and orientation in space (i.e., withreference to frame 8; the combination of translational position androtation orientation defining a unique pose of an object inthree-dimensional space) and then be held stationary in that desiredposition and orientation during surgery performed with the use oftelesurgical system 2.

As shown, proximal coupling component 10 includes a first opening 12 anda second opening 13. First opening 12 is sized to receive one or moretelesurgical system instruments 14 of telesurgical system 2. A clusterof three telesurgical system instruments 14 is show—an endoscopic camera14 a and two therapeutic instruments 14 b (e.g., grasping, cutting, orelectrosurgical instruments, and the like). This instrument cluster isillustrative of various combinations of telesurgical system instruments14 that may be received through first opening 12 into the interior 6 ofenvelope 3. Second opening 13 is sized to receive one or more assistinstruments 15 (e.g., grasping, cutting, electrosurgical,suction/irrigation, or stapling instruments, and the like). In someimplementations the one or more assist instruments 15 are manuallyoperated (illustrated by the hand symbol), and in other optionalimplementations the one or more assist instruments 15 are operated viatelesurgical system 2 (illustrated in dashed line connection). Althougha single second opening 13 is shown, proximal coupling component 10 mayoptionally include two, three, or more second openings to receivevarious combinations of additional manual or teleoperated assistinstruments.

Distal coupling component 9 is removably coupled to patient 16 andsurrounds a body opening 17—either an incision or a natural orifice,such as the anus. During a surgical procedure, telesurgical systeminstruments 14 are received into envelope 3 and extend towards itsdistal opening 5. In this way, telesurgical system instruments 14 maywork at the patient's skin surface 18, within the patient's body wall19, or at a surgical site 20 distal of the body wall 19.

FIGS. 1B-1D are schematic cross-sectional views that illustrate in moredetail the coupling of the distal end of instrument access device 1 to aport device 21 located at body opening 17 in a patient in variousembodiments. Port device 21 retracts the patient's tissue and so keepsopening 17 open to allow surgical instruments to enter. As shown in FIG.1B, port device 21 may have a generally fixed diameter and be adjustablein height as shown by the double-headed arrow so that it can betightened against the patient's skin surface 18 and an interior surface22 of body wall 19. (An example of this type of port device 21 iscommonly referred to as a wound retractor, or by similar terms.)Alternatively, as shown in FIG. 1C, distal coupling component 9 may beremovably or fixedly coupled to another type of port device 21 a, whichgenerally has a fixed diameter and a fixed height and is inserted intoopening 17. (An example of this type of port device 21 a is an anal portused during transanal surgery.) Alternatively, distal coupling component9 may be removably or fixedly coupled to yet another type of port device21 b, which generally has a fixed diameter and a fixed height and isplaced on the patient's skin surface, for example by adhesive orsuction. If envelope 3 is sufficiently stiff, then a distally-directedforce transmitted from proximal coupling component 10 (receiving, forexample, a distally-directed force from telesurgical system 2) throughenvelope 3 may be sufficient to maintain port device 21 b in position.Alternatively, a structural support (not shown) may be coupled to portdevice 21 b and used to keep port device 21 b in position. This type ofport device 21 b allows the surgical instruments to work at or slightlybelow the patient's skin surface (e.g., to make an incision or todissect tissue immediately under the skin surface). Other variations ofport devices optionally may be used. If the distal coupling component 9is removably coupled to a port device, then distal coupling component 9may be optionally coupled to any of port devices 21, 21 a, or 21 b, orto any other style of port device used during a surgical procedure. Thatis, a single instrument access device 1 may be used with any of two ormore ports devices, depending on the surgery to be performed. Distalcoupling component 9 optionally includes a clamp (not shown) or othersuitable device that may be used to removably couple distal couplingcomponent 9 to a port device. It should be noted that although gaspressure used to insufflate a body cavity for surgery can also be usedto insufflate envelope 3, the instrument access device and associatedcomponents optionally may be used in clinical situations in whichpatient insufflation gas is not used, in which case insufflation gas maybe used solely to hold envelope 3 in its desired shape or to otherwiseprovide clinical benefits such as smoke evacuation from within envelope3.

FIG. 1E is a schematic cross-sectional view that illustrates proximalelements of instrument access device 1 in more detail. During surgery,teleoperated instruments 14 are inserted through first opening 12 alongtelesurgical instrument insertion axis 23, and one or more assistinstruments 15 are inserted through second opening 13 generally alongassist instrument insertion axis 24. If it becomes necessary to insertan assist instrument 15 into envelope 3 to a location 25 that is blockedby one or more telesurgical instruments 14, then the position of secondopening 13 must move with reference to the position of first opening 12so that the assist instrument 15 can reach the desired location 25.Therefore, since first opening 12 and its associated telesurgicalinstrument insertion axis 23 are stationary with reference to globalframe 8, second opening 13 and its associated assist instrumentinsertion axis 24 must orbit around first opening 12 (i.e., telesurgicalinstrument insertion axis 23) until second opening 13 and its associatedassist instrument insertion axis 24 are at a position from which assistinstrument 15 can reach the location 25. But, even though the distalcoupling component 9 of envelope 3 is fixed with reference to frame 8when coupled to a patient, envelope 3 should not twist around centeraxis 7 as second opening 13 and assist instrument insertion axis 24orbit around first opening 12 and telesurgical instrument insertion axis23.

In one aspect, telesurgical instrument insertion axis 23 is offset fromcenter axis 7; in an alternate aspect, telesurgical instrument insertionaxis 23 is coincident with center axis 7; in yet another alternateaspect, alternate instrument insertion axis 24 is offset from centeraxis 7; and in still another alternate aspect, alternate instrumentinsertion axis 24 is coincident with center axis 7. Therefore it can beseen that if one of the center axis 7, telesurgical instrument insertionaxis 23, or assist instrument insertion axis 24 is held stationary inspace, the other two axes if offset from the stationary axis will orbitaround the stationary axis without envelope 3 twisting. It can also beseen that if the center axis 7 is coincident with telesurgicalinstrument insertion axis 23 or assist instrument insertion axis 24,then if the coincident axes are held stationary in space the remainingnon-coincident axis will orbit around the coincident axes withoutenvelope 3 twisting, and if the remaining non-coincident axis is heldstationary in space, the coincident axes will orbit around the remainingnon-coincident axis without envelope 3 twisting. Likewise, a similarrelationship between fixed axes (single or coincident) and orbiting axes(single or coincident) exists for implementations in which two, three,or more optional second openings 13 are used. The following descriptionconcentrates on aspects in which the telesurgical instrument insertionaxis is fixed in space and offset from center axis 7, to avoid prolixdescription; skilled persons will understand that the describedimplementations can easily be modified to similarly describe otherimplementations in which the center axis 7 or assist instrumentinsertion axis 24 is fixed in space, and other implementations thatinclude coincident axes.

FIG. 2 is a schematic top view that illustrates operating features ofproximal coupling component 10. Referring to FIGS. 1E and 2 together,proximal coupling component 10 includes an inner stationary element 10a, an outer element 10 b, and an orbital element 10 c between stationaryelement 10 a and outer element 10 b. Stationary element 10 a is coupledto mechanical ground (e.g., via coupling 11 as described above) so that,during a surgical procedure, element 10 a remains stationary at adesired position and orientation with reference to reference frame 8until a clinician moves stationary element 10 a to a different (second)desired position and orientation if necessary. Outer element 10 b iscoupled to envelope 3 at proximal opening 4 and remains stationaryrelative to proximal opening 4. Orbital element 10 c is coupled tostationary element 10 a and rotates around stationary element 10 a atteleoperated instrument insertion axis 23.

During use, when the distal opening 5 is fixed in space (e.g., whendistal coupling component 9 is coupled to a port device), envelope 3will undesirably twist if proximal opening 4 is rotated. Therefore,orbital element 10 c includes a countermotion mechanism 10 d that iscoupled to outer element 10 b, so that, as orbital element 10 c rotatesin a first direction around stationary element 10 a by an angular amountθ, countermotion mechanism 10 d rotates outer element 10 b relative toorbital element 10 c by an equal angular amount θ but in an oppositedirection of rotation from orbital element 10 c's direction of rotationaround stationary element 10 a (i.e., −θ). And since the two rotationsare by equal angular amounts but in opposite directions, outer element10 b's orientation does not change with reference to frame 8, andenvelope 3 does not twist around center axis 7 when distal couplingcomponent 9 is stationary with reference to frame 8. That is, proximalopening 4, distal opening 5, stationary element 10 a, outer element 10 band distal coupling component 9 all remain in the same relativeorientation to one another as orbital element 10 c rotates withreference to them. It can further be seen that since stationary element10 a is fixed in space, outer element 10 b and orbital element 10 ctranslate in position with reference to frame 8 (−x, y, as shown fororbital element 10 c's rotation angle θ) as orbital element 10 c orbitsaround stationary element 10 a. But since envelope 3 is flexible orsufficiently movable with reference to distal opening 5 and distalcoupling component 9, its proximal opening 4 can translate withreference to its distal opening 5 without any accompanying twisting ofenvelope 3 around center axis 7.

Referring to FIG. 1E, telesurgical instruments 14 are inserted throughfirst opening 12 via an optional telesurgical instrument entry guide 26.Non-limiting examples of telesurgical system entry guides 26 thataccommodate two or more telesurgical instruments 14 are disclosed inU.S. Pat. No. 9,877,744 B2 (filed Feb. 12, 2010)(disclosing “Entry Guidefor Multiple Instruments in a Single Port Surgical System”) and U.S.Pat. No. 9,757,149 B2 (filed Jun. 16, 2014) (disclosing “Surgical SystemEntry Guide”), and also in International Patent Application Pubs. No. WO2018/013730 A1 (filed Jul. 12, 2017) (disclosing “Surgical InstrumentGuide”) and WO 2018/013734 A1 (filed Jul. 12, 2017) (disclosing“Surgical Instrument Guide with Insufflation Channels”), all of whichare incorporated herein by reference.

In some implementations, entry guide 26 is inserted through an optionalentry guide receptacle 27, which is inserted through stationary element10 a and performs the function of an entry guide cannula. In otheroptional implementations, entry guide receptacle 27 is combined with orconstitutes stationary element 10 a, and entry guide 26 is inserteddirectly through stationary element 10 a, which in this case performsthe function of an entry guide cannula.

To prevent insufflation gas under pressure from leaking from interior 6of envelope 3 through entry guide 26 with or without telesurgicalinstruments 14 inserted through entry guide 26, or through receptacle 27(or stationary element 10 a functioning as an entry guide receptacle)either with or without an entry guide 26 inserted through receptacle 27(or stationary element 10 a functioning as an entry guide receptacle),various gas seal arrangements may be used. Non-limiting examples ofentry guide seals 28 are disclosed in U.S. Patent Application Pub. No.US 2014/0276464 A1 (filed Mar. 14, 2014)(disclosing “Sealing MultipleSurgical Instruments”), which is incorporated herein by reference.

Insufflation gas under pressure may be introduced into the interior 6 ofenvelope 3 via stationary element 10 a, or via entry guide 26, or viareceptacle 27, or via seal 28, or by an arrangement of any of these fourelements combined together to define a gas flow path. For example, ifaspects of stationary element 10 a and receptacle 27 are combined into asingle element and an entry guide seal 28 is used, insufflation gas maybe introduced via these combined elements. As illustrated, insufflationgas from an insufflation gas source 29 travels along a gas flow path 30into interior 6 of envelope 3. As a result, an insufflation gas pressure31 higher than the ambient atmospheric pressure outside of envelope 3 ismaintained in interior 6.

Alternatively, insufflation gas may be introduced into the interior 6 ofenvelope 3 via gas flow paths other than illustrated by gas flow path30, such as an instrument seal in second opening 13 (described below),or such as a dedicated insufflation port in orbital element 10 c,envelope 3, or distal coupling component 9. And optionally, one or moregas flow paths from interior 6 to outside envelope 3 may be defined,illustrated by the reverse direction of gas flow path 30. Such anoutward gas flow path may be used for functions such as smoke evacuationif a teleoperated instrument 14 or an assist instrument 15 is not usedto perform a smoke evacuation function.

Envelope 3 may have various shapes and may be made of various materials.For example, envelope 3 may have a generally spheroid shape, a generallyellipsoid shape (i.e., flattened or elongated with reference to centeraxis 7), a generally ovoid shape (i.e., tapered at one end along centeraxis 7), a generally cylindrical shape around center axis 7, or otherthree-dimensional shape of clinical benefit (e.g., generally conical,generally prism-shaped, and the like).

Envelope 3 may be made of flexible plastic sheeting that assumes thedesigned shape when sufficient insufflation gas pressure 31 existswithin interior 6 of envelope 3. Optionally, envelope 3 may be made of aflexible, resilient material that holds its shape without the need forinterior gas pressure. In still other options, structural elements(e.g., support ribs or similar structures) are used to help envelope 3hold its shape during use. And in still other options, envelope isrigid.

Envelope 3 may be generally transparent so that a clinician outsideenvelope 3 may view the pose of an instrument 14, 15 within envelope 3.Alternatively, envelope 3 may be opaque, in which case an image from anendoscopic camera within envelope 3 may be used to determine the pose ofan instrument 14, 15 within envelope 3. As another alternative, envelope3 may be opaque with one or more transparent windows.

Still referring to FIG. 1E, an assist instrument 15 is inserted throughsecond opening 13 via an assist instrument seal 32. Instrument seal 32functions to maintain insufflation gas pressure within envelope 3 whenan assist instrument 15 is either inserted or not inserted. Varioussuitable instrument seals are known and may be used, and non-limitingexamples of an instrument seal 32 are disclosed in U.S. PatentApplication Pub. No. 2017/0095269 A1 (filed Mar. 17, 2015) and inInternational Patent App. No. PCT/US2019/031393 (filed May 8, 2019)(disclosing “Instrument Seal”), which are incorporated herein byreference.

Further aspects and details will now be described.

Telesurgical System

To illustrate the general context in which an instrument access deviceas described above may be used, FIG. 3 provides a schematic perspectiveview that illustrates aspects of a telesurgical system in accordancewith various embodiments. In general, for the purposes of thisdescription, a telesurgical system includes three main components: anendoscopic imaging system, a user control system (master), and amanipulator system 210E (slave) (shown in FIG. 3 ), all interconnectedby wired (electrical or optical) or wireless connections. One or moredata processors (i.e., one or more logical units coupled to one or morememory systems) may be variously located in these main components toprovide system functionality. Examples are disclosed in U.S. Pat. No.9,060,678 (filed Jun. 13, 2007) (disclosing “Minimally Invasive SurgicalSystem”), which is incorporated by reference herein.

The imaging system performs image processing functions on, e.g.,captured endoscopic imaging data of the surgical site and/orpreoperative or real-time image data from other imaging systems externalto the patient. The imaging system outputs processed image data (e.g.,images of the surgical site, as well as relevant control and patientinformation) to a surgeon at user control system. In some aspects, theprocessed image data is output to an optional external monitor visibleto other operating room personnel or to one or more locations remotefrom the operating room (e.g., a surgeon at another location may monitorthe video; live feed video may be used for training; etc.).

The user control system includes multiple-degrees-of-freedom mechanicalinput devices that allow the surgeon to manipulate the instruments,entry guide(s), and imaging system devices, with computer assistance.These input devices may in some aspects provide haptic feedback from theinstruments and surgical device assembly components to the surgeon. Theuser control system also includes a stereoscopic video output displaypositioned such that images on the display are generally focused at adistance that corresponds to the surgeon's hands working behind/belowthe display screen.

Control during insertion and use of the instruments may be accomplished,for example, by the surgeon moving the instruments presented in theimage with one or two of the input devices; the surgeon uses the inputdevices to translate and rotate the instrument in three-dimensionalspace. Similarly, one or more input devices may be used to translate androtate the imaging system or an associated surgical device assembly tosteer an endoscope or instrument cluster towards a desired location onthe output display and to advance inside the patient.

A manipulator system 210E is illustrated in FIG. 3 . In the depictedexample, the manipulator system 210E is implemented as a patient-sidecart, and the surgery is in the abdomen of patient 229. However, thesurgical system including manipulator system 210E can be used for a widevariety of surgeries by using various combinations of instruments.

Manipulator system 210E includes a floor-mounted base 201E as shown, oralternately a ceiling-mounted or other mechanically grounded base (notshown). Base 201E may be movable or fixed (e.g., to the floor, ceiling,wall, or other equipment such as an operating table). Base 201E supportsthe remainder of the manipulator system, which includes a usuallypassive, uncontrolled manipulator support structure 220E and an activelycontrolled manipulator system 230E, herein also referred to as entryguide manipulator 230E.

In one example, the manipulator support structure 220E includes a firstsetup link 202E and two passive rotational setup joints 203E and 205E.Rotational setup joints 203E and 205E allow manual positioning of thecoupled setup links 204E and 206E. Alternatively, some of these setupjoints may be actively controlled, and more or fewer setup joints may beused in various configurations. Setup joints 203E and 205E and setuplinks 204E and 206E allow a person to place entry guide manipulator 230Eat various positions and orientations in Cartesian x, y, z space. Apassive prismatic setup joint (not shown) between link 202E ofmanipulator support structure 220E and base 201E may be used for largevertical adjustments 212E.

Entry guide manipulator 230E includes an entry guide manipulatorassembly 231E that supports a plurality of surgical device assemblies,at least one surgical device assembly being coupled to entry guidemanipulator assembly 231E during a surgery. Each surgical deviceassembly includes a teleoperated manipulator and either a surgicalinstrument or a camera instrument mounted on the manipulator. Forexample, in FIG. 3 , one surgical device assembly includes, mounted tomanipulator 240E, an instrument 260E with a shaft 262E that extendsthrough one of typically multiple channels of entry guide 270E during asurgical procedure.

Entry guide manipulator assembly 231E includes an instrument manipulatorpositioning system (hereinafter simply “positioning system”). Thepositioning system moves instrument mount interfaces of one or moremanipulators 240E in a plane so that, when one or more instruments 260Eare coupled to entry guide manipulator assembly 231E using therespective instrument mount interfaces, the shafts of the instruments260E are each aligned for insertion into one of the channels in entryguide 270E. While the entry guide 270E is depicted as located at a bodywall of the patient, it is to be understood that the manipulator system210E can also be used, without need for modifications, with entry guideslocated at a distance from the body wall in an entry guide receptacle ofan instrument access device as herein described.

The instrument mount interface(s) may be moved into position afterattachment of the instrument(s). The plane in which the instrument mountinterfaces are moved is generally perpendicular to the lengthwise axisof entry guide 270E, and the trajectories that instrument mountinterfaces take in that plane may include straight and/or curvedportions in various combinations. As a positioning element of a lateralmotion mechanism of the positioning system moves along a trajectory, theinstrument mount interface, and effectively a distal tip of a shaft ofan instrument coupled to the instrument mount interface, moves along thesame trajectory. Thus, motion of the positioning element causes theshaft to be moved to a location where the shaft is aligned with achannel in entry guide 270E. In this position, the shaft can enter andpass through the channel in entry guide 270E without damaging theinstrument and without inhibiting operation of the instrument. Theparticular paths implemented in the positioning system depend at leastin part on the types of surgical device assemblies that can be mountedon the entry guide manipulator assembly 231E and/or the configuration ofchannels in entry guide 270E.

Different entry guides may be used in different surgical procedures. Anentry guide that enters the body between the ribs may optionally have adifferent shape than an entry guide that enters the body through anincision in the abdomen. Further, entry guides that enter the bodygenerally differ, e.g., in length, from entry guides used outside thebody, such as entry guides inserted through an entry guide receptacle ata proximal end of an envelope of an instrument access device asdisclosed herein; entry guides used outside of and at a distance fromthe body may be shortened relative to those entering the body. Thedifferent shapes of the entry guides require different layouts of thechannels that extend through the entry guides, i.e., different channelconfigurations. Also, the shapes and/or sizes of the shafts of theinstruments may be different for different instruments. An entry guideis used that accommodates the shapes and sizes of the shafts of theinstruments used in a particular surgical procedure. The trajectoriesare designed to accommodate a set of entry guides that can be used withmanipulator system 210E.

The ability to individually position an instrument, and hence its shaft,with respect to a channel in an entry guide by moving an instrumentmount interface provides versatility to manipulator system 210E. Forexample, this ability allows entry guides with different channelconfigurations to be used in system 210E. In addition, the positioningsystem eliminates the need for surgical-procedure-specific instruments.In other words, the instrument manipulator positioning system allows useof a common set of instruments with a variety of entry guides by movingthe instrument shafts around, as described above.

Entry guide manipulator 230E includes a kinematic chain of active jointsand links that are movable by motors or other actuators and receivemovement control signals that are associated with master arm movementsat the user control system. Using this kinematic chain, the entry guidemanipulator 230E can adjust the position and orientation of thepositioning system of entry guide manipulator assembly 231E and, byextension, the instrument. Usually, the entry guide manipulator 230E isconfigured and operated to constrain rotation of an instrument at apoint located on the instrument's shaft, herein referred to as a remotecenter of motion.

Conventionally, the remote center of motion coincides generally with theposition at which an instrument enters the patient (e.g., at theumbilicus for abdominal surgery). In accordance with this disclosure,however, where an instrument access device with an instrument entryguide located outside the body (in a port at the proximal end of theenvelope of the instrument access device) is used, the position of theremote center of motion likewise falls outside the body. e.g., slightlyabove the body wall, and generally along the axis of the entry guide. Aremote center of motion above the body wall allows for instruments to bemoved radially outward from the entry guide's extended axis proximallyof the patient's body wall and so get better triangulation access at orin the incision. Flexible instrument shafts in conjunction with aflexible wound retractor render such flexibility in operating theinstruments possible without risking trauma to tissue.

The remote center of motion is the location at which yaw, pitch, androll axes intersect, i.e., the location at which the kinematic chain ofentry guide manipulator 230E remains effectively stationary while jointsmove through their range of motion. As shown in FIG. 3 , a manipulatorassembly yaw joint 211E is coupled between an end of setup link 206E anda first end, e.g., a proximal end, of a first manipulator link 213E. Yawjoint 211E allows first manipulator link 213E to move with reference tolink 206E in a motion that may be arbitrarily defined as “yaw” around amanipulator assembly yaw axis 223E. As shown, yaw axis 223E of joint211E is aligned with a remote center of motion located at or near theentry guide 270E.

A distal end of first manipulator link 213E is coupled to a proximal endof a second manipulator link 215E by a first actively controlledrotational joint 214E. A distal end of second manipulator link 215E iscoupled to a proximal end of a third manipulator link 217E by a secondactively controlled rotational joint 216E. A distal end of thirdmanipulator link 217E is coupled to a fourth manipulator link 219E by athird actively controlled rotational joint 218E; the fourth manipulatorlink 219E extends in both directions away from the rotational joint 218Eand, thus, has two distal ends relative to the location of the joint218E.

In one embodiment, links 215E, 217E, and 219E are coupled together toact as a coupled motion mechanism. Coupled motion mechanisms are wellknown (e.g., such mechanisms are known as parallel motion linkages wheninput and output link motions are kept parallel to each other). Forexample, if rotational joint 214E is actively rotated, then joints 216Eand 218E are also actively rotated so that link 219E moves with aconstant relationship to link 215E. Therefore, it can be seen that therotational axes of joints 214E, 216E, and 218E are parallel. When theseaxes are perpendicular to yaw axis 223E of joint 211E, links 215E, 217E,and 219E move with reference to link 213E in a motion that may bearbitrarily defined as “pitch” around a manipulator assembly pitch axis.The manipulator pitch axis extends into and out of the page in FIG. 3 atremote center of motion at or near the entry guide 270E. The motionaround the manipulator assembly pitch axis is represented by arrow 221E.Since links 215E, 217E, and 219E move as a single assembly in thisembodiment, first manipulator link 213E may be considered an activeproximal manipulator link, and second through fourth manipulator links215E, 217E, and 219E may be considered collectively an active distalmanipulator link.

An entry guide manipulator assembly platform 232E is coupled to one ofthe distal ends of fourth manipulator link 219E. Entry guide manipulatorassembly 231 is rotatably mounted on platform 232E. Entry guidemanipulator assembly 231 can rotate a plurality of surgical deviceassemblies (e.g., 260E) as a group around axis 225E. Specifically, entryguide manipulator assembly 231 rotates as a single unit with referenceto platform 232E in a motion that may be arbitrarily defined as “roll”around an entry guide manipulator assembly roll axis 225E.

In accordance with the present disclosure, all the instruments(including a camera instrument) enter the instrument access device via asingle port, which is generally stationary relative to the remote centerof motion imposed by entry guide manipulator 230E (and defined by theintersection of manipulator assembly yaw axis 223E, manipulator assemblypitch axis 221E, and manipulator roll axis 225E). The configuration oflinks 215E, 217E, and 219E, and the configuration of joints 214E, 216E,and 218E are such that remote center of motion is located distal ofentry guide manipulator assembly, with sufficient distance to allowentry guide manipulator assembly to move freely with respect to theentry guide.

An entry guide receptacle 275E may be removably coupled (directly orindirectly via a mount) to the distal end of fourth manipulator link219E opposite the distal end to which entry guide manipulator assemblyplatform 232E is coupled. In one implementation, the entry guidereceptacle 275E or mount is coupled to link 219E by a rotational jointthat allows it to move between a stowed position adjacent link 219E andan operational position that ensures that the remote center of motion islocated along the entry guide receptacle 275E or the entry guide 270Ereceived therein. During operation, the entry guide receptacle 275E isfixed in position relative to link 219E according to one aspect. Entryguide receptacles and entry guides may be made of various materials,e.g., steel or extruded plastic. Plastic, which is less expensive thansteel, may be suitable for one-time use per surgical procedure.

The various passive setup joints/links and active joints/links allowpositioning of the instruments and imaging system with a large range ofmotion when a patient 229 is placed in various positions on a movabletable. Certain setup and active joints and links in the manipulatorsupport structure 210E and/or entry guide manipulator 230E may beomitted to reduce the surgical system's size and shape, or joints andlinks may be added to increase degrees of freedom. It should beunderstood that the manipulator support structure 210E and entry guidemanipulator 230E may include various combinations of links, passivejoints, and active joints (redundant degrees of freedom may be provided)to achieve a necessary range of poses for surgery.

Instrument Access Devices with Countermotion Mechanisms

FIG. 4A is an exploded perspective view of an example instrument accessdevice 400 in accordance with various embodiments. In FIG. 4A,instrument access device 400 includes entry guide receptacle assembly402 (including entry guide receptacle 426), countermotion assembly 404,envelope 406, and clamp 408 (serving as distal coupling component). Theentry guide receptacle 426 and countermotion assembly 404 together formthe proximal coupling component in this embodiment.

Clamp 408 is received in a distal opening of envelope 406, and, in use,affixes instrument access device 400 to a wound retractor or similarport device at a body opening. Countermotion assembly 404 is received ina proximal opening 418 of envelope 406, and it includes a first port 410that receives the entry guide receptacle 426 and is therefore alsoreferred to as the “entry guide port” 410, and a second port 420 thatcan receive assist instruments and is therefore also referred to as the“assistant port” 420. One or more instruments enter instrument accessdevice 400 at the proximal end through an entry guide received in entryguide receptacle 426 or through the assistant port 420. Envelope 406also includes an additional envelope assistant port 422 through whichfurther instruments can enter. The instruments (whether entering throughthe entry guide port 410 or either of the assistant ports 420, 422)either work within envelope 406 or leave it through the distal openingto enter the patient's body. The assistant port 422 may optionally beconfigured to allow surgical equipment (e.g., suture or mesh material,imaging probes, instrument accessories, and the like) to be introducedor removed from the interior of envelope 406, or to allow tissue to beremoved from the interior of envelope 406.

Entry guide receptacle assembly 402 includes entry guide receptacle 426as well as a connector 416 that affixes instrument access device 400 toan arm of a teleoperated surgical system, such as the system depictedand described with reference to FIG. 3 . Further, entry guide receptacleassembly 402 includes gas lines 412 and 414, which carry insufflationgas through the lines and into instrument access device 400, includinginto envelope 406. The insufflation lines 412, 414 may have standardflow Luer fittings or, alternatively, other fittings that permit ahigher gas flow volume over time. The use of two gas lines 412, 414serves to enable connecting an insufflation source to either side of theentry guide port 410, which can accommodate spatial constraints insurgical setting. Further, the two gas lines 412, 414 allow one line tobe used for insufflation and the other line to be used for smokeevacuation, e.g., by venting the second line to the room or using aninsufflator with built-in smoke evacuator.

Countermotion assembly 404 includes an orbital element 424 (as anexample of element 10 c) in which the openings of the entry guide port410 and the assistant port 420 are defined, an outer element 425 (as anexample of element 10 b) received in the proximal opening of theenvelope 406, and a countermotion mechanism that rotates assistant port420 around entry guide port 410 (and, thus, entry guide receptacle 426)without envelope 406 twisting about a central axis of the envelope 406.In use, when the instrument access device is affixed to a telesurgicalsystem, entry guide receptacle 426 remains stationary in space asassistant port 420 rotates around it. (In this embodiment, entry guidereceptacle 426 serves the function of the stationary component 10 a.)

FIG. 4B is an exploded perspective view depicting additional details ofinstrument access device 400. In FIG. 4B, entry guide receptacleassembly 402 includes entry guide receptacle 426, instrument guide seal428, seal support 430, cover 432, entry guide receptacle O-ring 434, andentry guide receptacle retaining ring 436. Instrument guide seal 428 isreceived in entry guide receptacle 426. Cover 432 locks onto entry guidereceptacle 426, capturing (or “sandwiching”) seal support 430 andinstrument guide seal 428 between the cover 432 and entry guidereceptacle 426. Entry guide receptacle O-ring 434 is received in entryguide port 410 and seals the outer surface of the lumen of entry guidereceptacle 426 in port 410. Entry guide receptacle retaining ring 436couples entry guide receptacle 426 into entry guide port 410 and therebyconnects entry guide receptacle assembly 402 to countermotion assembly404.

In some examples, entry guide receptacle assembly 402 is configured toreceive an instrument entry guide, which is configured to receive andseal multiple instruments through a single port. In such cases,instrument guide seal 428 is configured to receive and seal theinstrument entry guide. In an example, instrument guide seal 428 caninclude a cross-slit seal, duckbill seal, wiper seal, septum seal, oranother type of seal appropriate for receiving and sealing an instrumententry guide in accordance with this disclosure. In an example,instrument guide seal 428 includes a seal similar to that disclosed inInternational Application No. PCT/US2019/031393 (filed May 8, 2009)(disclosing an “INSTRUMENT SEAL”), the entire contents of which areincorporated herein by reference.

In FIG. 4B, countermotion assembly 404 includes orbital element 424,which includes entry guide port 410 and assistant port 420. In addition,countermotion assembly 404 includes assistant port seal 438 and envelopeO-ring 440. Assistant port seal 438 is received in and is coupled toassistant port 420. Assistant port seal 438 is configured to receive andseal a manually operated instrument and can include a variety of typesof seals, including a cross-slit, duckbill, wiper, or septum seal. In anexample, assistant port seal 438 includes a seal similar to thatdisclosed in International Application No. PCT/US2019/031393. EnvelopeO-ring 440 is received in proximal opening 418 of envelope 406 and isconfigured to seal outer element 425 of countermotion assembly 404 inopening 418. Together with O-ring 434, O-ring 440 is important forholding insufflation while allowing the assistant port 420 to rotateabout the entry guide port 410. The instrument access device 402 alsoincludes an envelope assistant port seal 442, which is received inenvelope assistant port 422 of envelope 406. Envelope assistant portseal 442 is configured to receive and seal a manually operatedinstrument and can include a variety of types of seals, including across-slit, duckbill, wiper, or septum seal. In an example, envelopeassistant port seal 442 includes a seal similar to that disclosed inInternational Application No. PCT/US2019/031393.

FIG. 4C is a bottom plan view depicting gear train 450 in accordancewith one embodiment. Gear train 450 is a mechanism by which assistantport 420 is able to rotate around entry guide receptacle 426 and entryguide port 410 without envelope 406 rotating about a central axis of theenvelope, or, in other words, without envelope 406 twisting. Gear train450 includes first gear 452, second gear 454, idler gear 456, andintermediate gear 458. In FIG. 4C, first gear 452 and second gear 454are ring gears, with the gear teeth of first gear 452 facing radiallyinward and the gear teeth of second gear 454 facing radially outward.Intermediate gear 458 is a step spur gear including third spur gear 460and fourth spur gear 462 (hidden behind third spur gear 460) engagedwith idler gear 456 (partially hidden behind third spur gear 460). Thirdand fourth spur gears 460, 462 are coaxially coupled and rotatetogether.

First gear 452 is positioned around the outer periphery of orbitalelement 424 of countermotion assembly 404, and it is configured to beaffixed to outer element 425, which is coupled to proximal opening 418of envelope 406. Second gear 454 is coupled to the outer periphery ofentry guide receptacle 426. Note that the first and second gears 452,454 are located in different planes, second gear 454 being above (thatis, in the bottom-up view, below) first gear 452, and they do notdirectly operatively engage each other. The first and second gears 452,454 are coupled via idler gear 456 and intermediate gear 458 (allcollectively forming countermotion mechanism 10 d). More specifically,idler gear 456 operatively engages second gear 454 and fourth gear 462of intermediate gear 458. Fourth gear 462 is coupled to third gear 460of intermediate gear 458, which, in turn, operatively engages first gear452. Idler gear 456 reverses the direction of rotation between firstgear 452 and second gear 454. In particular, from the perspective of theview of FIG. 4C, idler gear 456 rotates counter-clockwise whenintermediate gear 458 (including third and fourth gears 460 and 462)rotates clockwise.

In the example of FIG. 4C, gear train 450 is depicted in a firstposition. To illustrate motion of the gear train 450, and by associationassistant port 420, gear train 450 is depicted in two additionalpositions in FIGS. 4D and 4E. Referring to FIGS. 4C-4E, note first thatsecond gear 454 and, by association, entry guide receptacle 426 stayfixed in space and do not either translate or rotate relative to thetelesurgical system. (Entry guide port 410 is likewise translationallyfixed in space but rotates along with the orbital element relative tothe entry guide receptacle.) Idler gear 456 is operatively engaged withand rotates around second gear 454. As idler gear 456 turns as ittranslates around second gear 454, idler gear 456 turns fourth spur gear462 of intermediate gear 458, which, in turn causes third spur gear 460of intermediate gear 458 to turn. As third spur gear 460 turns, itrotates first gear 452 and causes first gear 452 to translate around acentral axis of entry guide port 410 without rotating about the centralaxis of first gear 452. This is the manner in which assistant port 420is able rotate around entry guide port 410 and entry guide receptacle426 without causing envelope 406 (which is coupled to first gear 452) totwist. Note that, along with first gear 452 and the outer element 425 ofthe countermotion mechanism, the proximal opening of the envelope 406translates as well and thereby changes its position relative to thedistal opening of the envelope 406. This relative motion between theproximal and distal openings is accommodated by the flexible or movablenature of the envelope 406.

This swinging translation of first gear 452 (and by association envelope406) about entry guide port 410 is enabled, at least in part, by thegear ratios of the various gears of gear train 450; the gear ratios arechosen such that the rotations remain synchronized in that a rotation ofthe first gear 452 relative to the idler gear 456 by a certain angle inone direction is accompanied by a rotation of the second gear 454relative to the idler gear 452 by the same angle in the oppositedirection. In particular, a gear ratio of the third spur gear 460 to thefourth spur gear 462 is equal to a gear ratio of first gear 452 tosecond gear 454. The motion of first gear 452 can be tracked in FIGS.4A-4E by reference to index mark 464 on the outer element 425 and gear452. Note that while index mark 464 translates relative to entry guidereceptacle 426 and entry guide port 410, the mark 464 and thereforefirst gear 452 do not rotate. Or in other words, the first gear stays ina fixed rotational orientation relative to entry guide receptacle 426and entry guide port 410.

FIG. 5A is a bottom perspective view depicting gear train 550 inaccordance with another embodiment. Gear train 550 is another mechanismby which assistant port 420 is able to rotate around entry guidereceptacle 426 and entry guide port 410 without envelope 406 rotatingabout a central axis of the envelope, or in other words without envelope406 twisting. Gear train 550 includes first gear 552, second gear 554,and intermediate gear 556. In FIG. 5A, first gear 552 and second gear554 are ring gears with the gear teeth of first gear 552 and second gear554 facing radially inward. Additionally, intermediate gear 556 is astep spur gear including third spur gear 560 and fourth spur gear 562,so that gears 560 and 562 are coaxially coupled and rotate together.

First gear 552 is positioned around the outer periphery of orbitalelement 424 of countermotion assembly 404 and is configured, along withouter element 425, to be positioned in and coupled to proximal opening418 of envelope 406 (see FIGS. 4A and 4B). Second gear 554 is positionedaround the outer periphery of entry guide receptacle 426. Intermediategear 556 is positioned between first gear 552 and second gear 554. Thirdspur gear 560 of intermediate gear 556 operatively engages first gear552. Fourth spur gear 562 of intermediate gear 556 operatively engagessecond gear 554.

FIG. 5B is a bottom plan view depicting gear train 550. In the exampleof FIG. 5B, gear train 550 is depicted in a first position. Toillustrate motion of the gear train 550, and by association orbitalelement 424, which includes assistant port 420, gear train 550 isdepicted in two additional positions in FIGS. 5C and 5D. Referring toFIGS. 5B-5D, note first that second gear 554, and by association entryguide receptacle 426, stay fixed in space and do not either translate orrotate relative to other components. Fourth spur gear 562 ofintermediate gear 556 rotates around and is operatively engaged tosecond gear 554. As fourth spur gear 562 rotates around second gear 554,third spur gear 560 of intermediate gear 556 engages and turns firstgear 552, which causes first gear 452 to translate around a central axisof entry guide port 410 without rotating relative to the central axis offirst gear 552. This is the manner in which assistant port 420 is ableto rotate around entry guide port 410 and entry guide receptacle 426without causing envelope 406 (which is coupled to first gear 552) totwist.

This swinging translation of first gear 552 (and by association envelope406) about entry guide port 410 is enabled, at least in part, by thegear ratios of the various gears of gear train 550. In particular, agear ratio of the third spur gear 560 to the fourth spur gear 562 isequal to a gear ratio of first gear 552 to second gear 554. The motionof first gear 552 can be tracked in FIGS. 5B-5D by reference to indexmark 564 on the outer element 425 and gear 552. Note that while indexmark 564 translates relative to entry guide receptacle 426 and entryguide port 410, the mark 564, and therefore first gear 552 do notrotate. In other words, the first gear stays in a fixed rotationalorientation relative to entry guide receptacle 426 and entry guide port410.

FIG. 6A is a bottom perspective view depicting gear train 650 inaccordance with yet another embodiment. Gear train 650 is anothermechanism by which assistant port 420 is able to rotate around entryguide receptacle 426 and entry guide port 410 without envelope 406rotating about a central axis of the envelope, or in other words withoutenvelope 406 twisting. Gear train 650 includes first gear 652, secondgear 654, and intermediate gear 656, and it operates in a manner similarto gear train 550 with the differences that, as shown in FIG. 6A, firstgear 652 and second gear 654 are ring gears with the gear teeth of firstgear 652 and second gear 654 facing radially outward, and intermediategear 656 is a step spur gear including third spur gear 660 and fourthspur gear 662 located outside the first and second ring gears 652, 654.

First gear 652 is positioned around the outer periphery of orbitalelement 424 of countermotion assembly 404 and is configured, along withthe outer element 425, to be positioned in and coupled to proximalopening 418 of envelope 406 (see FIGS. 4A and 4B). Second gear 654 ispositioned around the outer periphery of entry guide receptacle 426.Intermediate gear 656 is positioned between first gear 652 and secondgear 654. In this example, the outer element 425 includes threeoutward-protruding optional tabs 666, and intermediate gear 656, whichincludes third and fourth spur gears 660, 662, is arranged within one ofthe three tabs 666. Tabs 666 can serve multiple functions, includinghousing intermediate gear 656 and providing finger grips to manipulatecountermotion assembly 404 to rotate assistant port 420. Third spur gear660 of intermediate gear 656 operatively engages first gear 652. Fourthspur gear 662 of intermediate gear 656 operatively engages second gear654.

FIG. 6B is a bottom plan view depicting gear train 650 in accordancewith this disclosure. In the example of FIG. 6B, gear train 650 isdepicted in a first position. To illustrate motion of the gear train650, and by association orbital element 424 and assistant port 420, geartrain 650 is depicted in two additional positions in FIGS. 6C and 6D.Referring to FIGS. 6B-6D, note first that second gear 654 and byassociation entry guide receptacle 426 stay fixed in space and do noteither translate or rotate relative to other components. Fourth spurgear 662 of intermediate gear 656 rotates around and is operativelyengaged to second gear 654. As fourth spur gear 662 rotates aroundsecond gear 654, third spur gear 660 of intermediate gear 656 engagesand turns first gear 652, which causes first gear 652 to translatearound a central axis of entry guide port 410 without rotating about thecentral axis of first gear 652. This is the manner in which assistantport 420 is able rotate around entry guide port 410 and entry guidereceptacle 426 without causing envelope 406 (which is coupled to firstgear 652) to twist.

This swinging translation of first gear 652 (and by association envelope406) about entry guide port 410 is enabled, at least in part, by thegear ratios of the various gears of gear train 650. In particular, agear ratio of the third spur gear 660 to the fourth spur gear 662 isequal to a gear ratio of first gear 652 to second gear 654. The motionof first gear 652 can be tracked in FIGS. 6B-6D by reference to indexmark 664 on the outer element 425 and gear 652. Note that while indexmark 664 translates relative to entry guide receptacle 426 and entryguide port 410, the mark 664 and therefore first gear 652 do not rotate.In other words, the first gear stays in a fixed rotational orientationrelative to entry guide receptacle 426 and entry guide port 410.

FIG. 7A is a top perspective view of proximal coupling component 700 ofanother instrument access device in accordance with various embodiments.The proximal coupling component 700 includes entry guide receptacleassembly 702 and countermotion assembly 704. The envelope (coupled toproximal coupling component) and clamp (disposed in and coupled to thedistal opening of the envelope) of the instrument access device are notshown. The envelope and clamp are the same or similar to those depictedin FIGS. 4A and 4B for instrument access device 400.

Countermotion assembly 704 includes inner hub 706, outer rim 708, andcrank arm 710. Inner hub 706 includes entry guide port 712 and assistantport 714. Entry guide port 712 and assistant port 714 are positionedeccentrically on inner hub 706. Outer rim 708 is coupled to theenvelope. Inner hub 706 is rotatable relative to outer rim 708 about acentral axis of outer rim 708. Entry guide receptacle assembly 702,which includes entry guide receptacle 716 and connector 718, is receivedin entry guide port 712. Crank arm 710 is pivotally connected to outerrim 708. Connector 718 affixes instrument access device 700 to an arm ofa teleoperated surgical system, such as the system depicted anddescribed with reference to FIG. 3 .

Inner hub 706, outer rim 708, crank arm 710, and entry guide receptacleassembly 702 are connected to one another to form a linkage. The linkageis configured to rotate assistant port 714 around entry guide receptacle716 without the envelope connected to outer rim 708 rotating about acentral axis of the envelope. Thus, the linkage allows assistant port714 to rotate around entry guide receptacle 716 without twisting theenvelope.

In the example of FIG. 7A, inner hub 706, outer rim 708, crank arm 710,and entry guide receptacle assembly 702 are connected to one another toform a 4-bar linkage 724, more specifically, a parallel 4-bar linkage.Entry guide receptacle assembly 702 is the ground link of the 4-barlinkage, and crank arm 710 is the input link of the linkage. Inner hub706 and outer rim 708 are each coupler links of the 4-bar parallellinkage formed by inner hub 706, outer rim 708, crank arm 710, and entryguide receptacle assembly 702. The four axes of rotation associated withthe joints of the linkage 724, where pairs of adjacent links arecoupled, are depicted with dashed lines in FIG. 7A. At the first axis730, the crank arm 710 is coupled to the entry guide receptacle assembly702 (at or near the connector 718 of the entry guide receptacle assembly702). The second axis 732, which goes through the center of the entryguide port, corresponds to the joint that couples the entry guidereceptacle assembly 702 to the inner hub 706. The third axis 734, whichgoes through the common center of the rim 708 and hub 706, correspondsto the joint that couples the hub 706 to the outer rim 708. The fourthaxis 736, which is the pivot axis of the crank arm 710, couples the rim708 to the crank arm 710. The distance between axes 730, 736 (the lengthof the crank-arm link) is equal to the distance between axes 732, 734(the distance between the centers of the rim and the entry guide port),and the distance between axes 730, 732 is equal to the distance betweenaxes 734, 736, such that the axes 730, 732, 734, 736 form aparallelogram.

Countermotion assembly 704 also includes a locking mechanism for lockinglinkage 724 from moving and thereby for locking assistant port 714 in aposition relative to entry guide receptacle 716 and entry guide port712. In FIG. 7A, lock arm 720 is deflectable relative to outer rim 708and includes a catch on an underside of lock arm 720. Outer rim 708includes ratchet teeth 722. Lock arm 720 is resilient and configured tolock into ratchet teeth 722. Lock arm 720 can be deflected to raise thelock arm out of engagement with ratchet teeth 722 and thereby unlock thelinkage formed by inner hub 706, outer rim 708, entry guide receptacleassembly 702, and crank arm 710, which in turn allows assistant port 714to rotate relative to and about entry guide receptacle 716 and entryguide port 712.

FIG. 7B is a plan view depicting linkage 724 formed by inner hub 706,outer rim 708, entry guide receptacle assembly 702, and crank arm 710.In the example of FIG. 7B, linkage 724 is depicted in a first position.To illustrate motion of linkage 724, and by association assistant port714, linkage 724 is depicted in two additional positions in FIGS. 7C and7D. The axes of rotation 730, 732, 734, 736 are indicated by black dotsin these plan views. Referring to FIGS. 7B-7D, note first that entryguide receptacle 716 stays fixed in space and does not either translateor rotate relative to other components. Crank arm 710 is pivotablerelative to inner hub 706 and outer rim 708. Pivoting crank arm 710causes inner hub 706 to rotate relative to outer rim 708. Additionally,pivoting crank arm 710 causes outer rim 708, which is connected to theenvelope, to translate without rotating about a central axis of outerrim 708. This is the manner in which assistant port 714 is able torotate around entry guide receptacle 716 and entry guide port 712without causing the envelope (which is coupled to outer rim 708) totwist.

Envelope

As noted above, examples according to this disclosure include aninstrument access device that includes an envelope, and the envelopeincludes a distal opening at a distal end, a proximal opening at aproximal end, and a cavity between the distal and proximal ends andopenings. The distal end of the envelope is coupled to a distal couplingcomponent, which may be or include, e.g., a clamp. The clamp or otherdistal coupling component can, in turn, be coupled to a wound retractoror other port device. The proximal end of the envelope is coupled to aproximal coupling component, e.g., one including a countermotionassembly as described above. The instrument access device is configuredto receive an insufflation gas and to maintain insufflation pressurewithin a cavity in the body of a patient and to maintain insufflationpressure within the cavity of the envelope. The pressurized and sealedenvelope cavity provides an operating space for shafts of multipleinstruments of a teleoperated surgical system to articulate outside thebody such that instrument end effectors can be located at or near thesurface of the body at the incision site of the wound retractor coupledto the instrument access device.

In examples according to this disclosure, the pressurized envelope isconfigured to allow shafts of multiple instruments of a teleoperatedsurgical system to triangulate within the cavity of the envelope. Thus,the envelope needs to provide enough space to allow multiple instrumentsto be manipulated within the cavity of the envelope and to allow asurgeon to triangulate the instruments to perform various procedures ator near the surface of the body at the incision site of the woundretractor coupled to the instrument access device. U.S. Pat. No.9,060,678 B2 (filed Jun. 13, 2007) discloses aspects of instrumenttriangulation in a single-port surgical system and is hereinincorporated by reference.

The pressurized envelope may be (but need not be) manufactured from atransparent material, including, for example, a transparent polymer.Beneficially, a transparent envelope provides visualization for aclinician to see the incision site to which the envelope is connected.In use of the instrument access device, the envelope is connected to aproximal coupling component (similar to the examples described abovewith reference to FIGS. 4A-7D) that can receive medical instruments viaone or more ports (e.g., a primary entry guide port and an assistantport), and the envelope can provide visualization for the clinician forinstruments introduced via these ports. When an opaque material is usedfor the envelope, visualization can be provided by an endoscopic camerainserted into the instrument access device via one of the ports, oroptionally by one or more transparent windows in the envelope.

In various embodiments, the envelope of the instrument access device,when pressurized with insufflation gas or when constructed withsufficient rigidity, extends radially outward beyond the proximal anddistal openings in the envelope (and thus beyond the portions of theproximal and distal coupling components received in the respectiveopenings). Example shapes and configurations of the envelope aredescribed with respect to FIGS. 8A-8F.

FIG. 8A is a perspective view depicting example instrument access device800 according to various embodiments. In FIG. 8A, instrument accessdevice 800 includes envelope 802, distal coupling component 804, entryguide receptacle assembly 806, and countermotion assembly 808. Entryguide receptacle assembly 806 and countermotion assembly 808 can besimilar to the entry guide receptacle assemblies and countermotionassemblies described above with reference to FIGS. 4A-7D. For example,entry guide receptacle assembly 806 includes entry guide receptacle 810and countermotion assembly 808 includes orbital element 812 having entryguide port 814 and assistant port 816, surrounded by outer element 813.

Envelope 802 includes distal opening 818 and proximal opening 820.Distal opening 818 of envelope 802 is coupled to and receives clamp (orother distal coupling component) 804, which is configured to beconnected to a port device, such as a wound retractor assembly, at anincision site. Proximal opening 820 of envelope 802 is coupled to andreceives countermotion assembly 808. Distal opening 818 of envelope 802can be coupled to clamp 804 by a variety of means, including using anadhesive, or heat-sealing envelope 802 to clamp 804. Similarly, proximalopening 820 of envelope 802 can be coupled to countermotion assembly 808by a variety of means, including using an adhesive, or heat-sealingenvelope 802 to countermotion assembly 808 at the outer element 813.

As will be described in greater detail below, envelope 802 can be of avariety of shapes and sizes. In general, however, envelope 802, oncondition that envelope 802 is pressurized with insufflation gas or ifsufficiently rigid, extends radially outward beyond clamp 804 andcountermotion assembly 808. In the example of FIG. 8A, envelope 802includes proximal section 822 and distal section 824. Proximal section822 of envelope 802 is coupled to distal section 824 at junction 826.Proximal section 822 can be coupled to distal section 824 by a varietyof means, including using an adhesive, or heat-sealing proximal section822 to distal section 824. Proximal section 822 and distal section 824may each be a single contiguous piece, or be alternatively formed ofmultiple pieces. In multi-piece sections 822, 824, the proximal opening820 may be formed in a first piece included in the proximal section 822,and the distal opening 818 may be formed in a second piece included inthe distal section 824.

Proximal section 822 of envelope 802 can be a first convex section.Distal section 824 of envelope 804 can be a second convex sectiongenerally opposed to proximal convex section 822. The combination ofproximal section 822 and distal section 824 can form an ovoid shape asshown (e.g., as characterized by two convex portions that meet at acommon maximum diameter, but generally differ in height). As will bedescribed in detail below, other shapes are also possible. In thedepicted example, the maximum diameter of envelope 802 is located atjunction 826 connecting proximal section 822 to distal section 824. Inan example, the maximum diameter of envelope 802 is optionally largerthan the longitudinal height of envelope 802. Additionally, junction 826can be located below a transverse plane that bisects envelope 802longitudinally (in a direction along a center axis defined through thedistal and proximal openings 818 and 820 of the envelope). In otherwords, with proximal section 822 of the envelope 802 extending a firstdistance along the center axis and the distal section 824 of theenvelope 802 extending along a second distance along the center axis,the second distance can be less than the first distance. Locatingjunction 826 below the longitudinal midpoint of envelope 802 can improvevisualization for a clinician by providing a larger field of viewthrough proximal section 822 that is unobstructed by junction 826.

Envelope 802 includes an optional additional assistant port 828.Envelope assistant port 828 includes seal 830, which is received in port828 of envelope 802. Envelope assistant port seal 830 is configured toreceive and seal a manually operated instrument and can include avariety of types of seals, including a cross-slit, duckbill, wiper,and/or septum seal. In the example of FIG. 8A, envelope assistant portseal 830 includes a cross-slit seal. In another example, envelopeassistant port seal 830 includes a seal similar to the seals disclosedin International Application No. PCT/US2019/031393 (filed May 8, 2019),which is herein incorporated by reference.

Envelope 802 (and other envelopes in accordance with this disclosure)can be manufactured from a variety of materials, including a variety oftransparent polymers. In an example, envelope 802 is manufactured fromacetates, polyester, vinyl, or urethanes (e.g., thermoplasticpolyurethane (TPU)). Envelope 802 can be manufactured in a variety ofways, including vacuum forming. In another example, envelope 802 ismanufactured from a flat panel with multiple seams, which are joined toone another to form the final shape of envelope 802.

FIGS. 8B-8F are perspective views depicting additional example envelopesin accordance with this disclosure. The same materials as listed abovemay be used for the envelopes of FIGS. 8B-8F as well. In FIG. 8B,instrument access device 832 includes envelope 834, clamp 836, entryguide receptacle assembly 838, and countermotion assembly 840. Entryguide receptacle assembly 838 and countermotion assembly 840 can besimilar to the entry guide receptacle assemblies and instrument sealassemblies described above with reference to FIGS. 4A-7D.

Envelope 834 includes distal opening 850 and proximal opening 851.Distal opening 850 of envelope 834 is coupled to and receives clamp 836,which is configured to be connected to a port device, such as a woundretractor assembly at an incision site. Proximal opening 851 of envelope834 is coupled to and receives countermotion assembly 840. Distalopening 850 of envelope 834 can be coupled to clamp 836 by a variety ofmeans, including using an adhesive, or heat-sealing envelope 834 toclamp 836. Similarly, proximal opening 851 of envelope 834 can becoupled to countermotion assembly 840 by a variety of means, includingusing an adhesive or heat-sealing envelope 834 to countermotion assembly840 at the outer element.

In the example of FIG. 8B, envelope 834 has a substantially sphericalshape (allowing for some deviations from perfect spherical shape, e.g.,to accommodate for the proximal and distal openings). Although notdepicted in FIG. 8B, in examples, spherical envelope 834 may be formedfrom two or more semi-spherical sections joined together at a seam orother junction.

Envelope 834 includes, optionally, an additional assistant port 852.Envelope assistant port 852 includes seal 853, which is received in port852 of envelope 834. Envelope assistant port seal 853 is configured toreceive and seal a manually operated instrument and can include avariety of types of seals, including a cross-slit, duckbill, wiper,and/or septum seal. In the example of FIG. 8A, envelope assistant portseal 853 includes a cross-slit seal. In another example, envelopeassistant port seal 853 includes a seal similar to seals disclosed inInternational Application No. PCT/US2019/031393.

Envelope 834 can be manufactured in a variety of ways, including vacuumforming. In another example, envelope 834 is manufactured from a flatpanel with multiple seams, which are joined to one another to form thefinal shape of envelope 834.

Referring now to FIG. 8C, instrument access device 854 includes envelope855, clamp 856, entry guide receptacle assembly 857, and countermotionassembly 858. Entry guide receptacle assembly 857 and countermotionassembly 858 can be similar to the entry guide receptacle assemblies andinstrument seal assemblies described above with reference to FIGS.4A-7D.

Envelope 855 includes distal opening 862 and proximal opening 863.Distal opening 862 of envelope 855 is coupled to and receives clamp 856,which is configured to be connected to a port device, such as a woundretractor assembly at an incision site. Proximal opening 863 of envelope855 is coupled to and receives countermotion assembly 858. Distal end862 of envelope 855 can be coupled to clamp 856 by a variety of means,including using an adhesive, or heat-sealing envelope 855 to clamp 856.Similarly, proximal end 863 of envelope 855 can be coupled tocountermotion assembly 858 by a variety of means, including using anadhesive, or heat-sealing envelope 855 to countermotion assembly 858 atthe outer element.

In the example of FIG. 8C, envelope 855 has an oblate spheroid shape.Although not depicted in FIG. 8C, in examples, oblate spheroid envelope855 may be formed from two or more semi-spheroid sections which arejoined together at a seam or other junction. Although not depicted inFIG. 8C, envelope 855 can optionally include an additional assistantport having an assistant port seal as described above.

In FIG. 8D, instrument access device 864 includes envelope 865, clamp866, entry guide receptacle assembly 867, and countermotion assembly868. Entry guide receptacle assembly 867 and countermotion assembly 868can be similar to the entry guide receptacle assemblies and instrumentseal assemblies described above with reference to FIGS. 4A-7D.

Envelope 865 includes distal opening 872 and proximal opening 873.Distal opening 872 of envelope 865 is coupled to and receives clamp 866,which is configured to be connected to a port device, such as a woundretractor assembly at an incision site. Proximal opening 873 of envelope865 is coupled to and receives countermotion assembly 868. Distal end872 of envelope 865 can be coupled to clamp 866 by a variety of means,including using an adhesive, or heat-sealing envelope 865 to clamp 866.Similarly, proximal end 873 of envelope 865 can be coupled tocountermotion assembly 868 by a variety of means, including using anadhesive, or heat-sealing envelope 865 to countermotion assembly 868 atthe outer element.

In the example of FIG. 8D, envelope 865 has a generally cylindricalshape, and more specifically a cylindrical bellows shape. Although notdepicted in FIG. 8D, in examples, bellows-shaped envelope 865 may beformed from two or more sections joined together at seam(s) or otherjunction(s). Additionally, although not depicted in FIG. 8D, envelope865 can optionally include an additional assistant port having anassistant port seal.

In FIG. 8E, instrument access device 874 includes envelope 875, clamp876, entry guide receptacle assembly 877, and countermotion assembly878. Entry guide receptacle assembly 877 and countermotion assembly 878can be similar to the entry guide receptacle assemblies and instrumentseal assemblies described above with reference to FIGS. 4A-7D.

Envelope 875 includes distal opening 882 and proximal opening 883.Distal opening 882 of envelope 875 is coupled to and receives clamp 876,which is configured to be connected to a port device, such as a woundretractor assembly at an incision site. Proximal opening 883 of envelope875 is coupled to and receives countermotion assembly 878. Distal end882 of envelope 875 can be coupled to clamp 876 by a variety of means,including using an adhesive, or heat-sealing envelope 875 to clamp 876.Similarly, proximal opening 883 of envelope 875 can be coupled tocountermotion assembly 878 by a variety of means, including using anadhesive, or heat-sealing envelope 875 to countermotion assembly 878.

In the example of FIG. 8E, envelope 875 has a lenticular shape. Thelenticular-shaped envelope 875 includes first and second convex sections884, 885 sharing a common maximum diameter. The two convex sections 884,885 are positioned opposite one another, and they are joined in anequatorial region 886, where the common maximum diameters of the twosections 884, 885 meet. In the example of FIG. 8E, the envelope 875includes rib 887 at the equatorial region 886, and rib 887 extendsradially outward from first convex section 885 and second convex section886. Rib 887 provides structural support around the perimeter ofequatorial region 886 to prevent, for example, inward buckling of thelenticular shape at the equatorial region 886 under insufflationpressure.

The two sections 884, 885 of lenticular-shaped envelope 875 may besymmetrical as shown, or they may be of different sizes. For example,proximal convex section 884 may have a larger longitudinal height thandistal convex section 885 to provide enhanced visibility inside theenvelope as described above. The proximal and convex sections may bejoined together at seam(s) or other junction(s). Additionally, althoughnot depicted in FIG. 8E, envelope 865 can optionally include anadditional assistant port having an assistant port seal as describedabove.

In FIG. 8F, instrument access device 888 includes envelope 889.Instrument access device 888 can be substantially similar to instrumentaccess device 874 of FIG. 8E, except that its envelope 889, instead ofbeing lenticular-shaped like envelope 875, includes an elongatedvertical section 892 between the two (e.g., convex) top and bottomsections 890, 891. Thus, envelope 889 generally has the shape of abarrel (e.g., bulging outward in the center, or, alternatively, beingsubstantially cylindrical) bounded at the top and bottom by convex or,alternatively, flat or generally flat surfaces. Envelope 889, whenpressurized with insufflation gas, extends radially outward beyond aclamp or other distal coupling component as well as beyond thecountermotion assembly of a proximal coupling component. Envelope 889may include an assistant port and seal (not shown) as described above.

Entry Guide

As explained above, various instrument access devices in accordance withthis disclosure (e.g., devices 400, 700, 800, 832, 854, 864, 874, 888)are configured to receive an instrument entry guide in an entry guidereceptacle located in an entry guide port of the instrument accessdevice. An example such entry guide is described in the followingdisclosure.

FIG. 9A is a perspective view of an instrument entry guide 900 inaccordance with various embodiments. The entry guide 900 includes afunnel portion 902 at the proximal end and, connected to the distal endof the funnel portion 902, a shaft portion 904. Multiple instrumentchannels are defined in entry guide 900, and each instrument channelincludes an optional proximal tapered lead-in portion 906 in funnelportion 902 and a distal lumen 908 in shaft portion 904. Four instrumentchannels are shown, and other optional implementations may include two,three, or more instrument channels. Each instrument channel isconfigured to receive and guide an instrument through the entry guide toemerge from the distal end of the lumen 908. The cross sections of theinstrument channels may all have the same size and shape, or they mayvary in size and/or shape to guide different instruments through theentry guide.

FIG. 9B is a top view of entry guide 900, showing the funnel portions902 and its tapered lead-in portions 906 at the proximal end of theentry guide 900 of FIG. 9A. FIG. 9B illustrates instrument channels(lead-in portions 906 and lumens 908) of different cross-sectionalshapes and sizes in accordance with one embodiment. One lumen 910 has arelatively larger round cross section than round cross section lumens912. In one optional implementation, lumen 910 is sized to receive aninstrument comprising an instrument shaft with a diameter of 14millimeters or less, such as diameters in the range of 10-14millimeters. Two lumens 912 have relatively smaller round cross sectionsthan lumen 910. These lumens 912 are optionally sized to each receive aninstrument with an instrument shaft having a diameter of 7 millimetersor less, such as diameters that are approximately 6.5 millimeters. Thecross section of the fourth lumen 914 is oval in shape, and it issuitable to accommodate, e.g., a camera instrument. The relative sizesand cross-sectional shapes of the lumens 910, 912, 914 illustrate thatvarious combinations of lumen sizes and cross section shapes may be usedin implementations of entry guide 900.

FIG. 9C is an exploded perspective view of the entry guide 900 thatillustrates further detail. As shown, the funnel portion 902 may beformed of two parts: an upper part 920 and a lower part 922. The lowerpart 922 optionally may be integrally formed with the shaft 904. Theentry guide 900 further includes an instrument seal 924 captured betweenthe upper and lower parts 920, 922 of the funnel portion 902. The sealmay be made, e.g., of silicone. During manufacturing, the instrumentseal 924 can be seated in the lower part 922, and the upper part 924 canthen be snapped into the lower part 922, with an O-ring 926 sealing thetwo parts along their rims. The instrument seal 924 includes sealopenings 928 aligned with the instrument channels 906 and lumens 908,and the seal openings 928 are sized and shaped to accommodate anassociated instrument outer diameter. The entry guide 900 furtherincludes pivoting seal doors 930 each aligned with one of the sealopenings 928 and the associated instrument channel 906. In someembodiments, the entry guide also includes levers 932 to manuallyoperate the doors 930. (Some, but not all, of the pivoting doors 930 andlevers 932 are shown exploded off to the side.)

The doors 930 may be spring-loaded and biased to the closed state. Inits closed state, each door engages with and seals against theinstrument seal 924, with a sealing portion of the door sealing one ofthe seal openings 928. When an instrument is inserted through a lead-inportion 906 of the funnel portion 902 and into a corresponding lumen inthe shaft 904, the door 930 associated with the lumen is pushed open.When a door 930 is in an open state, the lip of corresponding sealopening 928 seals against the shaft of the instrument extending throughthe corresponding instrument channel. The instrument seal 924 inconjunction with the sealing door 930 prevents insufflation gas fromescaping through an instrument channel when no instrument is insertedand from escaping between the inner wall of the channel and theinstrument shaft when an instrument is inserted. Further details ofentry guides and associated sealing aspects are described in U.S. Pat.No. 9,629,681 B2 (filed Mar. 14, 2014)(disclosing “Sealing MultipleSurgical Instruments”), which is herein incorporated by reference.

FIG. 9D is a cross-sectional view of the entry guide 900, taken along alongitudinal axis of the entry guide 900 (i.e., along the direction ofthe shaft 904). Unlike prior entry guides, entry guide 900 is configuredto slightly bend the shafts of one or more of the inserted instruments.In prior entry guide configurations, the instrument channels in an entryguide are configured so that instrument shafts, despite entering theinstrument channels in the funnel portion 902 from generally differentdirections, exit the lumens 908 of the shaft 904 substantially parallelto each other and to the longitudinal axis of the entry guide 900 (e.g.,deviating from the longitudinal axis by no more than 1 degree). In priorentry guides, this reorientation of the instrument shafts to begenerally parallel is achieved by curving the distal ends of the lumens908 slightly radially outward, compensating for the remainingorientational bias of the instrument shafts that results from theradially inward component of their orientation where they enter theinstrument channels. But this straightening effect is insufficient tokeep the instrument shafts parallel upon exiting the lumens 908 when thelength of the shaft 904 of the entry guide 900 is shortened, e.g., tominimize the space the shaft 904 takes up inside the envelope of aninstrument access device in accordance with the present disclosure.Thus, if the entry guide shaft 904 is shortened without furthercompensating for the inward orientational bias of resiliently bendableinstrument shafts entering the proximal end of the entry guide, theinstrument shafts will cross or collide after they exit the entry guidelumens 908.

To remedy this problem and keep the instrument shafts parallel at theexit of the lumens 908 of a shortened entry guide, one or more of thelumens 908 are modified to include a small projection 940 at theirdistal ends. Projection 940 extends radially inward into to the lumen908 to deflect the instrument shaft extending through the lumen radiallyoutward from the lumen's centerline and the entry guide's central axis.The projection 940 in a lumen may be positioned on the central junctionbetween the multiple lumens such that it points away from the centralaxis of the entry guide shaft 904. The projection 940 is sized andshaped to deflect and orient a shaft of an instrument parallel to thelongitudinal axis of the entry guide shaft 904. The size and shape ofthe projection 940 may, for instance, depend on the flexibility of theinstrument shaft of the instrument intended to be received in therespective lumen 908. Some instruments extending through instrumentchannels in entry guide 900 may have shafts that are sufficiently rigidthat no projection 940 is required at the distal end of theseinstruments' corresponding instrument channel. And so, for example, anentry guide 900 as depicted in FIG. 9B may have projections at the endsof the three lumens 910, 912 intended to receive surgical instruments,whereas the lumen 914 for the camera may lack such a projection becausethe camera shaft is sufficiently rigid. In general, however, an entryguide in accordance herewith may include inward projections 940 in anyone or more, including all, lumens.

In some embodiments the projection 940 at the distal end of lumen 908forms a ramp that defines a lumen diameter that decreases from aproximal end of the ramp to a distal end of the ramp, and the ramp ispositioned toward a center of the shaft 904 at the junction between thelumens 908.

In accordance with a further aspect, entry guide 900 may optionallyinclude a relief that defines an aperture in the outer periphery of theentry guide shaft 904 at a position opposite to the projection or ramp.This aperture extends the diameter of the lumen 908 outward and soallows for the extra bend in the instrument shaft. That is, the apertureprovides extra room for the instrument shaft to bend outward, where theshaft would otherwise contact the outer wall of the lumen. Although theprojections as described above reorient the instrument shafts into agenerally parallel configuration after exiting the distal end of theentry guide, in optional alternate embodiments the projections in thelumens 108 are configured to deliberately spread the instrumentslaterally to a laterally converging orientation or to a laterallydiverging orientation. In the laterally converging orientation, theprojections still spread the instrument shafts sufficiently to preventthe instruments from colliding during normal operation. In the laterallydiverging orientation, the projections spread the instrument shafts toprovide additional spacing between the instruments.

Torque Limiting Clutch

FIGS. 10A-10C depict an example medical device including a clutch inaccordance with examples of this disclosure. FIG. 10A is a partialsection view of example instrument access device 1000 including entryguide receptacle assembly 1002 and countermotion assembly 1004. Althoughnot depicted in FIG. 10A, in examples, instrument access device 1000 caninclude an envelope and wound retractor clamp (serving as distalcoupling component) substantially similar as described with reference tothe examples of FIGS. 4A-4E.

Countermotion assembly 1004 includes an orbital element 1024 in whichthe openings of the entry guide port and the assistant port are defined,an outer element 1025 received in the proximal opening of the envelope,and a countermotion mechanism that rotates the assistant port around theentry guide port without twisting the envelope about a central axis ofthe envelope. With regard to the countermotion mechanism of instrumentaccess device 1000, the example of FIGS. 10A-10C is substantiallysimilar in function, operation, and structure to the example of FIGS.4A-4E. However, the countermotion mechanism of countermotion assembly1004 includes a torque limiting clutch, which is configured to disengagecounterrotation of the countermotion mechanism in response to athreshold applied torque.

It has been discovered that under certain circumstances, a clinician orother user may operate an instrument access device in accordance withthis disclosure in a manner that applies a load on components of thecountermotion assembly/mechanism of the device, which can break orotherwise cause the failure of one or more components of thecountermotion assembly/mechanism. In some applications, for example, auser of an instrument access device, in the process of rotating theassistant port around the entry guide receptacle and entry guide port,may grab the envelope or a portion thereof and hold the envelope fixedto the outer element of the counterrotation assembly of the accessdevice. When a user grabs the envelope in this manner, the envelope isessentially forced to rotate with the rotation of the assistant portaround the entry guide receptacle and entry guide port. In thesecircumstances, the envelope pulls against the counterrotation action ofthe countermotion assembly/mechanism and places a relatively high loadon the components of the device, which can lead to wear or failure ofsuch components.

Referring to FIGS. 10A-10C, countermotion assembly 1004 includes geartrain 1050, which is a mechanism by which the assistant port is able torotate around the entry guide receptacle and entry guide port withoutthe envelope rotating about a central axis of the envelope, or, in otherwords, without twisting the envelope. Gear train 1050 includes firstgear 1052, second gear 1054, idler gear 1056, and intermediate gear1058. Intermediate gear 1058 is a step spur gear including third spurgear 1060 and fourth spur gear 1062 engaged with idler gear 1056. Asdepicted in FIGS. 10B and 10C, third spur gear 1060 includes first facegear 1064 and fourth spur gear 1062 includes second face gear 1066. Asillustrated by the example of FIGS. 10B and 10C, a face gear (sometimesreferred to as a crown gear) is a gear which has teeth that project atright angles to the face of the cylindrical shaped gear component(versus the teeth of spur gear 1060 or 1062, which project generallyparallel to the face). A face or crown gear is also defined as a type ofbevel gear where the pitch cone angle is 90 degrees.

In the example of instrument access device 1000, first face gear 1064 ofthird spur gear 1060 is biased into engagement with second face gear1066 of fourth spur gear 1062 by a section of orbital element 1024. Asdepicted in FIG. 10A, orbital element 1024 includes projections 1068,which extend distally from a proximal end of orbital element 1024 toabut fourth spur gear 1062. In operation at loads/torques below athreshold level, third and fourth spur gears 1060, 1062 are biased intoengagement with one another by projections 1068 of orbital element 1024and third and fourth spur gears 1060, 1062 rotate together.

In response to a load/torque above a threshold level, however, the loadthe user applies to the countermotion assembly 1004 overcomes theinherent spring force of orbital element 1024 to cause first face gear1064 to slip relative to the second face gear 1066 and to therebydecouple third spur gear 1060 from fourth spur gear 1062. When thirdspur gear 1060 disengages from fourth spur gear 1062, thecounterrotation of gear train 1050, which prevents the envelope fromtwisting, is disengaged and outer element 1025, orbital element 1024,and the envelope rotate around the entry guide port together in the samedirection. The resilience of orbital element 1024, applied to fourthspur gear 1062 via projections 1068 functions to automatically reengagethird and fourth spur gears 1060, 1062 and thus reengage thecounterrotation of gear train 1050 upon removal of or reduction in theload/torque applied by the user.

Instrument access devices in accordance with this disclosure can includeclutch or torque limiters that function similar to but are structureddifferently than the example clutch including first face gear 1064 ofthird spur gear 1060, second face gear 1066 of fourth spur gear 1062,and the resilient section of orbital element 1024. For example, thirdspur gear 1060 and fourth spur gear 1062 can be biased into engagementwith one another by a spring disposed within a cavity of countermotionassembly 1004. As another example, FIG. 11A and 11C depict analternative clutch that can be employed in instrument access device 1000to disengage the counterrotation of countermotion assembly 1004 (inparticular, gear train 1050) in response to a threshold applied torque.

FIGS. 11A and 11B depict an alternative torque limiting clutch, which isconfigured to disengage the counterrotation of a countermotion assemblyof an instrument access device in accordance with this disclosure. Theclutch of FIGS. 11A and 11B can be implemented at the junction/couplingbetween second gear 1054 of gear train 1050 and the outer periphery ofthe entry guide receptacle of instrument access device 1000. FIG. 11Adepicts example second gear 1054 with resilient fingers 1100 and FIG.11B schematically depicts second gear 1054 assembled on the outerperiphery of entry guide receptacle 1026, which includes protrusions1102 on either side of which pairs of fingers 1100 are arranged.

In operation at loads/torques below a threshold level, second gear 1054is configured to be fixedly coupled to entry guide receptacle 1026 suchthat second gear 1054 does not rotate around the entry guide receptacleperiphery. Second gear 1054 includes a plurality of resilient fingers1100 circumferentially distributed on an inner surface of the secondgear to engage a plurality of protrusions 1102 circumferentiallydistributed on an outer surface of entry guide receptacle 1026. Fingers1100 and protrusions 1000 are circumferentially distributed such thatpairs of resilient fingers 1100 are disposed on opposing sides of eachone of protrusions 1102 to hold second gear 1054 from rotating inresponse to a range of applied torques less than the threshold.

In response to a load/torque above a threshold level, however, the loadthe user applies overcomes the inherent spring force of fingers 1100 tocause the fingers to deflect radially outward and out of engagement withprotrusions 1102. In such circumstances, second gear 1054 is freed torotate relative to entry guide receptacle 1026, which, in turn, causesthe counterrotation of the gear train to disengage in a similar manneras described above with reference to FIGS. 10A and 10B. To reengage thecoupling between second gear 1054 and the outer periphery of entry guidereceptacle 1026, second gear 1054 need only be rotated by a load/torqueat least less than the threshold far enough for the pairs of fingers1100 to become reengaged with each of protrusions 1102.

EXAMPLES

The following numbered examples are illustrative embodiments:

1. A medical device comprising: an envelope comprising a proximalopening; and a proximal coupling component in the proximal opening ofthe envelope; the proximal coupling component comprising: an outerelement coupled to the envelope, an orbital element comprising a firstopening and a second opening, an entry guide receptacle received in thefirst opening, and a gear train coupling the entry guide receptacle tothe outer element; the gear train comprising: a first gear fixedlypositioned in the proximal opening of the envelope, a second gearfixedly coupled to a periphery of the entry guide receptacle, and one ormore intermediate gears engaged with the first and the second gears, thefirst gear being rotatable relative to the second gear without rotatingaround a central axis of the first gear, and the one or moreintermediate gears being rotatable and translatable relative to thefirst gear and the second gear.

2. The medical device of example 1, wherein: the orbital elementcomprises a center; and the first and second openings are positionedeccentrically on the orbital element.

3. The medical device of example 1 or example 2, wherein: movement ofthe plurality of gears rotates the orbital element and the second portaround the first port and the entry guide receptacle.

4. The medical device of any one of examples 1-3, wherein the one ormore intermediate gears comprise: an idler gear; and an intermediategear; the idler gear being engaged with the second gear and theintermediate gear; and the intermediate gear being engaged with theidler gear and the first gear.

5. The medical device of example 4, wherein: the intermediate gearcomprises a step gear comprising a third gear and a fourth gear coupledto the third gear; the third gear is engaged with the first gear; andthe fourth gear engaged with the idler gear.

6. The medical device of example 5, wherein: a gear ratio of the thirdgear to the fourth gear is equal to a gear ratio of the first gear tothe second gear.

7. The medical device of example 5 or example 6, wherein: the first gearand the second gear are ring gears; and the idler gear and theintermediate gear are spur gears.

8. The medical device of any one of examples 1-3, wherein: the one ormore intermediate gears comprise a step gear comprising a third gear anda fourth gear coupled to the third gear; the third gear being engagedwith the first gear; and the fourth gear being engaged with the secondgear.

9. The medical device of example 8, wherein: a gear ratio of the thirdgear to the fourth gear is equal to a gear ratio of the first gear tothe second gear.

10. The medical device of example 8, wherein: the first gear and thesecond gear are ring gears; and the third gear and the fourth gear arespur gears.

1. The medical device of any one of examples 1-10, wherein: the envelopepressurized with insufflation gas comprises a spherical shape.

12. The medical device of any one of examples 1-10, wherein: theenvelope pressurized with insufflation gas comprises an oblate sphericalshape.

13. The medical device of any one of examples 1-10, wherein: theenvelope pressurized with insufflation gas comprises a lenticular shape.

14. The medical device of any of examples 1-10, wherein: the envelopepressurized with insufflation gas comprises a barrel shape.

15. The medical device of any one of examples 1-10, wherein: theenvelope pressurized with insufflation gas comprises a bellows shape.

16. The medical device of any one of examples 1-10, wherein: theenvelope pressurized with insufflation gas comprises an ovoid shape.

17. The medical device of any one of examples 1-16, further comprising:a distal coupling component coupled to the distal opening of theenvelope.

18. The medical device of example 17, wherein: the distal couplingcomponent is configured to be coupled to a wound retractor assembly.

19. The medical device of any one of example 1-18, further comprising: amultiple instrument entry guide received in the entry guide receptacle.

20. The medical device of example 19, further comprising: an entry guideseal received in the entry guide receptacle; wherein the multipleinstrument entry guide is received in and sealed by the entry guideseal.

21. The medical device of any one of examples 1-20, further comprising:an instrument seal received in the second port.

22. The medical device of any one of examples 1-21, further comprising:a third port in the envelope between the proximal opening and the distalopening of the envelope.

23. The medical device of example 22, further comprising: an instrumentseal received in the third port.

24. A medical device comprising: an envelope comprising a proximalopening; and a proximal coupling component in the proximal opening ofthe envelope; the proximal coupling component comprising: an inner hubcomprising a first opening and a second opening, an outer rim coupled tothe envelope and surrounding the inner hub, an entry guide receptaclereceived in the first opening, and a crank arm pivotally connected tothe outer rim and the entry guide receptacle, the inner hub beingrotatable relative to the outer rim, the inner hub, the outer rim, theentry guide receptacle, and the crank arm being connected to one anotherto define a linkage, and movement of the linkage rotating the inner huband the second opening around the first opening and the entry guidereceptacle.

25. The medical device of example 24, wherein: the inner hub comprises acenter; and the first and second openings are positioned eccentricallyon the inner hub.

26. The medical device of example 24 ore example 25, wherein:

-   -   the linkage is a 4-bar linkage.

27. The medical device of example 26, wherein: a ground link of the4-bar linkage comprises the entry guide receptacle.

28. The medical device of example 26 or example 27, wherein: a couplerlink of the 4-bar linkage comprises the outer rim.

29. The medical device of any one of examples 26-28, wherein: a couplerlink of the 4-bar linkage comprises the inner hub.

30. The medical device of any one of examples 26-29, wherein: an inputlink of the 4-bar linkage comprises the crank arm.

31. The medical device of any one of examples 26-30, wherein: thelinkage comprises a parallel linkage.

32. The medical device of any one of examples 24-31, wherein: pivotingof the crank arm causes the inner hub to rotate relative to the outerrim.

33. The medical device of example 32, wherein: pivoting of the crank armcauses the outer rim to translate without rotating around a central axisof the outer rim.

34. A medical device comprising: means for enclosing a cavity, the meansfor enclosing comprising a proximal opening and central longitudinalaxis defined through the proximal opening; means for receiving one ormore instruments, the means for receiving being fixed in the proximalopening of the means for enclosing, and the means for receivingcomprising a first port and a second port; and means for rotating thesecond port around the first port without twisting the means forenclosing around the central longitudinal axis.

35. The medical device of example 34, wherein: the means for enclosingcomprises a distal opening; and the central longitudinal axis is definedthrough the distal opening.

36. The instrument a medical access device of example 34 or example 35,wherein: the means for rotating comprises a gear train; and movement ofthe gear train rotates the second port around the first port withouttwisting the means for enclosing around the central longitudinal axis.

37. The medical device of example 34 or example 35, wherein: the meansfor rotating comprises a linkage; and movement of the linkage rotatesthe second port around the first port without twisting the means forenclosing around the central longitudinal axis.

38. The medical device of example 34, wherein: the means for receivingcomprises: an orbital element fixedly coupled to the means forenclosing, the orbital element comprising the first port and the secondport, and an entry guide receptacle received in the first port; and themeans for rotating comprises: a gear train connecting the orbitalelement to the entry guide receptacle, wherein movement of the geartrain rotates the orbital element and the second port around the firstport and the entry guide receptacle.

39. The medical device of example 34, wherein: the means for receivingcomprises: an inner hub comprising the first port and the second port,an outer rim coupled to the means for enclosing, the outer rimsurrounding the inner hub, an entry guide receptacle received in thefirst port, and a crank arm pivotally connected to the inner hub and theouter rim; and the means for rotating comprises: a linkage defined bythe inner hub, the outer rim, the entry guide receptacle, and the crankarm, wherein movement of the linkage rotates the inner hub and thesecond port around the first port and the entry guide receptacle.

40. A medical device comprising: an envelope comprising a proximalopening; means for countermotion comprising: an outer element fixedlycoupled to the envelope at the proximal opening, an orbital elementsurrounded by the outer element, a first instrument port in the orbitalelement, a second instrument port in the orbital element, means forfixing the first instrument port at a fixed location in space, and meansfor counterrotating the outer element around the orbital element in afirst angular displacement in a first direction as the second instrumentport rotates around the first instrument port in a second angulardisplacement in a second direction, the second angular displacementbeing equal to the first angular displacement, and the second directionbeing opposite the first direction.

41. The medical device of example 40, wherein: the envelope comprises adistal opening opposite the proximal opening; the medical device furthercomprises means for clamping a port device; and the means for clampingis fixedly coupled to the envelope at the distal opening.

42. The medical device of example 40 or example 41, wherein: the meansfor counterrotating comprises gear means.

43. The medical device of example 40 or example 41, wherein: the meansfor counterrotating comprises bar linkage means.

44. A medical device comprising: an envelope comprising a proximalopening; and a proximal coupling component in the proximal opening ofthe envelope, wherein the proximal coupling component comprises: anouter element coupled to the envelope; an orbital element surrounded bythe outer element and comprising a first opening and a second opening;an instrument entry guide receptacle received in the first opening; anda mechanism coupling the entry guide receptacle to the outer element,wherein the mechanism comprises a clutch, wherein on condition a firsttorque below a threshold torque urges the orbital element to rotate in afirst direction, the mechanism rotates the orbital element and thesecond opening around the first opening in the first direction andcounterrotates the outer element and the envelope around the orbitalelement in a second direction opposite the first direction; and whereinon condition a second torque above the threshold torque urges theorbital element to rotate in the first direction, the mechanism rotatesthe orbital element and the second opening around the first opening inthe first direction, and the clutch disengages the counterrotation ofthe outer element and the envelope in the second direction.

45. The medical device of claim 44, wherein: the mechanism comprises agear train coupling the entry guide receptacle to the outer element.

46. The medical device of claim 45, wherein: the gear train comprises: afirst gear fixedly positioned in the proximal opening of the envelope; asecond gear coupled to a periphery of the entry guide receptacle; andone or more intermediate gears engaged with the first and the secondgears, the first gear is rotatable relative to the second gear withoutrotating around a central axis of the first gear, and the one or moreintermediate gears are rotatable and translatable relative to the firstgear and the second gear.

47. The medical device of claim 46, wherein: the one or moreintermediate gears comprise the clutch; and the clutch is configured todisengage the one or more intermediate gears from the first gear inresponse to the second torque.

48. The medical device of claim 47, wherein: the one or moreintermediate gears comprise a step spur gear, the step spur gearcomprises a third gear and a fourth gear; the clutch comprises a firstface gear biased into engagement with a second face gear by a resilientmember, the first face gear being on the third gear of the step spurgear, and the second face gear being on the fourth gear of the step spurgear; and on the condition the first torque urges the orbital element torotate in the first direction, a spring force of the resilient memberbiases the first face gear into engagement with the second face gear andthe third gear and the fourth gear rotate synchronously; and on thecondition the second torque urges the orbital element to rotate in thefirst direction, and the spring force of the resilient member isovercome and the first face gear slips relative to the second face gear.

49. The medical device of claim 48, wherein: the proximal couplingcomponent comprises a cavity, and the step spur gear is in the cavity;the orbital element defines a proximal wall of the cavity; and theresilient member comprises a portion of the orbital element thatdeflects in response to the second torque.

50. The medical device of claim 46, wherein: the clutch couples thesecond gear to the periphery of the entry guide receptacle; and theclutch is configured to disengage the counterrotation of the mechanismin response to the second torque by decoupling the second gear from theperiphery of the entry guide receptacle such that the second gearrotates relative to the entry guide receptacle.

51. The medical device of claim 50, wherein the clutch comprises: aprotrusion on the outer surface of the entry guide receptacle; at leastone resilient finger is on an inner surface of the second gear, whereinon the condition the first torque urges the orbital element to rotate inthe first direction, the at least one resilient finger engages theprotrusion to prevent the second gear from rotating relative to theentry guide receptacle, and wherein on the condition the second torqueurges the orbital element to rotate in the first direction, the at leastone resilient finger deflects out of engagement with the protrusion andthe second gear rotates relative to the entry guide receptacle.

52. The medical device of claim 51, wherein: the at least one resilientfinger comprises a first resilient finger and a second resilient finger;the protrusion comprises a first side and a second side opposite thefirst side; the first resilient finger is on the first side of theprotrusion; and the second resilient finger is on the second side of theprotrusion; on the condition the first torque urges the orbital elementto rotate in the first direction, the first and second resilient fingersengage the protrusion to prevent the second gear from rotating relativeto the entry guide receptacle; and on the condition the second torqueurges the orbital element to rotate in the first direction, the firstand second resilient fingers deflect out of engagement with theprotrusion and the second gear rotates relative to the entry guidereceptacle.

53. The medical device of claim 46, wherein: the one or moreintermediate gears comprise a step spur gear; the step spur gearcomprises a third gear and a fourth gear coupled to the third gear; thethird gear is engaged with the first gear; and the fourth gear isengaged with the second gear.

54. The medical device of claim 53, wherein: a gear ratio of the thirdgear to the fourth gear is equal to a gear ratio of the first gear tothe second gear.

55. The medical device of claim 53, wherein: the first gear and thesecond gear are ring gears; and the third gear and the fourth gear arespur gears.

56. The medical device of any of claims 44-55, wherein: the orbitalelement comprises a center; and the first and second openings arepositioned eccentrically on the orbital element.

57. The medical device of any one of claims 44-55, wherein: the envelopecomprises a distal opening; and the medical device further comprises adistal coupling component coupled to the distal opening of the envelope.

58. The medical device of claim 57, wherein: the distal couplingcomponent is configured to be coupled to a wound retractor assembly.

59. The medical device of any one of claims 44-55, further comprising: amultiple instrument entry guide received in the entry guide receptacle.

60. The medical device of claim 59, further comprising: an entry guideseal received in the entry guide receptacle; wherein the multipleinstrument entry guide is received in and sealed by the entry guideseal.

61. The medical device of any one of claims 46-55, further comprising:an instrument port in the envelope between the proximal opening and adistal opening of the envelope.

62. A medical device comprising: means for enclosing a cavity, the meansfor enclosing comprising a proximal opening and central longitudinalaxis defined through the proximal opening; means for receiving one ormore instruments, the means for receiving being in the proximal openingof the means for enclosing, and the means for receiving comprising afirst port and a second port; means for rotating the second port aroundthe first port without twisting the means for enclosing around thecentral longitudinal axis; and means for disengaging at least a portionof the means for rotating in response to a threshold applied torque.

63. The medical device of claim 62, wherein: on the condition the atleast a portion of the means for rotating is disengaged in response tothe threshold applied torque, the second port rotates around the firstport and the means for enclosing twists around the central longitudinalaxis.

64. The medical device of claim 62, wherein: the means for receivingcomprises a center; the central longitudinal axis intersects the center;and the first and second openings are positioned eccentrically on themeans for receiving.

65. The medical device of any one of claims 62-64, wherein: the meansfor rotating comprises a gear train, and the gear train comprises a stepspur gear comprising a third gear and a fourth gear; the means fordisengaging comprises a first face gear, a second face gear, and aresilient member that biases the first face gear into engagement withthe second face gear; the first face gear is on the third gear of thestep spur gear, and the second face gear is on the fourth gear of thestep spur gear; and on the condition the at least a portion of the meansfor rotating is disengaged in response to the threshold applied torque,a spring force of the resilient member is overcome and the first facegear slips relative to the second face gear.

66. The medical device of any one of claims 62-64, wherein: the meansfor rotating comprises a gear train, and the gear train comprises a gearfixedly coupled to a periphery of an instrument receptacle in the firstport; and the means for disengaging comprises a protrusion on theperiphery of the instrument receptacle and at least one resilient fingeron an inner surface of the gear and engaged with the protrusion toprevent the gear from rotating relative to the instrument receptacle;and on the condition the at least a portion of the means for rotating isdisengaged in response to the threshold applied torque, the resilientfinger disengages from the protrusion and the gear rotates relative tothe instrument receptacle.

Persons of skill in the art will understand that any of the featuresdescribed above may be combined with any of the other example features,as long as the features are not mutually exclusive. All possiblecombinations of features are contemplated, depending on clinical orother design requirements.

The examples (e.g., methods, systems, or devices) described herein maybe applicable to surgical procedures, non-surgical medical procedures,diagnostic procedures, cosmetic procedures, and non-medical proceduresor applications. The examples may also be applicable for training, orfor obtaining information, such as imaging procedures. The examples maybe applicable to handling of tissue that has been removed from human oranimal anatomies and will not be returned to a human or animal, or foruse with human or animal cadavers.

The above detailed description includes references to the accompanyingdrawings, which form a part of the detailed description. The drawingsshow, by way of illustration, specific embodiments in which theinvention may be practiced. These embodiments are also referred toherein as “examples.” Such examples may include elements in addition tothose shown or described. But, the present inventors also contemplateexamples in which only those elements shown or described are provided.Moreover, the present inventors also contemplate examples using anycombination or permutation of those elements shown or described (or oneor more aspects thereof), either with respect to a particular example(or one or more aspects thereof), or with respect to other examples (orone or more aspects thereof) shown or described herein.

In the event of inconsistent usages between this document and anydocuments so incorporated by reference, the usage in this documentcontrols.

In this document, the terms “a” or “an” are used, as is common in patentdocuments, to include one or more than one, independent of any otherinstances or usages of “at least one” or “one or more.” In thisdocument, the term “or” is used to refer to a nonexclusive or, such that“A or B” includes “A but not B,” “B but not A,” and “A and B,” unlessotherwise indicated. In this document, the terms “including” and “inwhich” are used as the plain-English equivalents of the respective terms“comprising” and “wherein.” Also, in the following claims, the terms“including” and “comprising” are open-ended, that is, a system, device,article, composition, formulation, or process that includes elements inaddition to those listed after such a term in a claim are still deemedto fall within the scope of that claim. Moreover, in the followingclaims, the terms “first,” “second,” and “third,” etc. are used merelyas labels, and are not intended to impose numerical requirements ontheir objects.

Geometric terms, such as “parallel”, “perpendicular”, “round”, or“square”, are not intended to require absolute mathematical precision,unless the context indicates otherwise. Instead, such geometric termsallow for variations due to manufacturing or equivalent functions. Forexample, if an element is described as “round” or “generally round”, acomponent that is not precisely circular (e.g., one that is slightlyoblong or is a many-sided polygon) is still encompassed by thisdescription. Coordinate systems or reference frames are provided foraiding explanation, and implantations may use other reference frames orcoordinate systems other than those described herein.

The above description is intended to be illustrative, and notrestrictive. For example, the above-described examples (or one or moreaspects thereof) may be used in combination with each other. Otherembodiments may be used, such as by one of ordinary skill in the artupon reviewing the above description. The Abstract is provided to allowthe reader to quickly ascertain the nature of the technical disclosure.It is submitted with the understanding that it will not be used tointerpret or limit the scope or meaning of the claims. Also, in theabove Detailed Description, various features may be grouped together tostreamline the disclosure. This should not be interpreted as intendingthat an unclaimed disclosed feature is essential to any claim. Rather,inventive subject matter may lie in less than all features of aparticular disclosed embodiment. Thus, the following claims are herebyincorporated into the Detailed Description as examples or embodiments,with each claim standing on its own as a separate embodiment, and it iscontemplated that such embodiments may be combined with each other invarious combinations or permutations. The scope of the invention shouldbe determined with reference to the appended claims, along with the fullscope of equivalents to which such claims are entitled.

1. A medical device comprising: an envelope comprising a proximalopening; and a proximal coupling component in the proximal opening ofthe envelope; the proximal coupling component comprising: an outerelement coupled to the envelope, an orbital element comprising a firstopening and a second opening, an entry guide receptacle received in thefirst opening, and a gear train coupling the entry guide receptacle tothe outer element; the gear train comprising: a first gear fixedlypositioned in the proximal opening of the envelope, a second gearfixedly coupled to a periphery of the entry guide receptacle, and one ormore intermediate gears engaged with the first and the second gears, thefirst gear being rotatable relative to the second gear without rotatingaround a central axis of the first gear, and the one or moreintermediate gears being rotatable and translatable relative to thefirst gear and the second gear.
 2. The medical device of claim 1,wherein: the orbital element comprises a center; and the first andsecond openings are positioned eccentrically on the orbital element. 3.The medical device of claim 1, wherein: movement of the plurality ofgears rotates the orbital element and the second opening around thefirst opening and the entry guide receptacle.
 4. The medical device ofclaim 1, wherein the one or more intermediate gears comprise: an idlergear; and an intermediate gear; the idler gear being engaged with thesecond gear and the intermediate gear; and the intermediate gear beingengaged with the idler gear and the first gear.
 5. The medical device ofclaim 4, wherein: the intermediate gear comprises a step gear comprisinga third gear and a fourth gear coupled to the third gear; the third gearis engaged with the first gear; and the fourth gear engaged with theidler gear.
 6. The medical device of claim 5, wherein: a gear ratio ofthe third gear to the fourth gear is equal to a gear ratio of the firstgear to the second gear.
 7. The medical device of claim 5, wherein: thefirst gear and the second gear are ring gears; and the idler gear andthe intermediate gear are spur gears.
 8. The medical device of claim 1,wherein: the one or more intermediate gears comprise a step gearcomprising a third gear and a fourth gear coupled to the third gear; thethird gear being engaged with the first gear; and the fourth gear beingengaged with the second gear.
 9. The medical device of claim 8, wherein:a gear ratio of the third gear to the fourth gear is equal to a gearratio of the first gear to the second gear.
 10. The medical device ofclaim 8, wherein: the first gear and the second gear are ring gears; andthe third gear and the fourth gear are spur gears.
 11. The medicaldevice of claim 1, wherein: the envelope pressurized with insufflationgas comprises a spherical shape.
 12. The medical device of claim 1,wherein: the envelope pressurized with insufflation gas comprises anoblate spherical shape.
 13. The medical device of claim 1, wherein: theenvelope pressurized with insufflation gas comprises a lenticular shape.14. The medical device of claim 1, wherein: the envelope pressurizedwith insufflation gas comprises a barrel shape.
 15. The medical deviceof claim 1, wherein: the envelope pressurized with insufflation gascomprises a bellows shape.
 16. The medical device of claim 1, wherein:the envelope pressurized with insufflation gas comprises an ovoid shape.17. The medical device of claim 1, further comprising: a distal couplingcomponent coupled to the distal opening of the envelope.
 18. The medicaldevice of claim 17, wherein: the distal coupling component is configuredto be coupled to a wound retractor assembly.
 19. The medical device ofclaim 1, further comprising: a multiple instrument entry guide receivedin the entry guide receptacle.
 20. The medical device of claim 19,further comprising: an entry guide seal received in the entry guidereceptacle; wherein the multiple instrument entry guide is received inand sealed by the entry guide seal. 21-66. (canceled)